Abstract
Study Objectives:
Home automatic positive airway pressure (APAP) therapy is becoming a mainstay treatment of obstructive sleep apnea. It is typically prescribed without any prior supervised titration. Initial experience of APAP treatment dictates subsequent use. Discomfort related to the APAP interface contributes to poor APAP adherence.
Methods:
After obtaining institutional review board approval, 156 adult patients newly diagnosed with obstructive sleep apnea were prospectively randomized into 2 groups (group A and group B). Group A received a 30-minute personalized interface/mask fitting session supervised by a certified sleep technician, during which APAP therapy was simulated and patients were educated on proper use. Patients sampled different interfaces to address any issues with comfort. Group B received usual care where patients obtained an interface through durable medical equipment suppliers. Primary endpoints included percent APAP usage (number of days APAP was used for ≥ 4 hours divided by 30 days) and APAP usage (number of days APAP was used for any duration) during the initial 30 days of home APAP therapy. Interface-associated air leak served as the secondary endpoint.
Results:
Mean percent APAP usage was higher in group A compared to group B (78.4% vs 67.8%; P = .04). On average, group A utilized the APAP machine on more days compared to group B (27 vs 24 days; P = .01). APAP interface associated air leak was lower in group A compared to group B (14.9 vs 21.1 l/min; P = .03).
Conclusions:
Our findings demonstrate that implementing a personalized interface fitting session supervised by a sleep technician improves APAP adherence.
Citation:
Syed Z, Mehta I, Hella JR, Barber K, Khorfan F. Implementing a sleep technician-supervised and personalized APAP interface fitting session prior to initiation of home APAP therapy improves adherence in patients with obstructive sleep apnea. J Clin Sleep Med. 2021;17(10):2057–2065.
Keywords: home sleep apnea test, obstructive sleep apnea, positive airway pressure, interface, interface air leak
BRIEF SUMMARY
Current Knowledge/Study Rationale: Positive airway pressure (PAP) is the most effective prescribed treatment for obstructive sleep apnea. The effectiveness of PAP therapy has been limited by poor adherence. Home sleep apnea testing and PAP therapy without direct supervision from qualified personnel is becoming more popular. Discomfort associated with the PAP interface is a major reason for poor adherence. There is a continued need to identify strategies to improve PAP adherence.
Study Impact: In this prospective, randomized study of 156 patients with obstructive sleep apnea treated with PAP therapy, implementing a sleep technician supervised PAP interface fitting in an outpatient sleep clinic resulted in improvement in PAP adherence and reduction in interface air leak as compared with usual care.
INTRODUCTION
Obstructive sleep apnea (OSA) is a common sleep disorder affecting 20% of adults, with 10% estimated to have moderate-to-severe disease.1 OSA places patients at an increased risk of daytime sleepiness, decreased quality of life, increased risk of motor vehicle accidents, and many other comorbidities.2–5 Positive airway pressure (PAP) therapy has been shown to result in a clinically significant reduction in disease severity, cardiovascular risk, and motor vehicle accidents while improving sleep-related quality of life in adults.6–8 Portable unsupervised home sleep testing and automatic PAP (APAP) therapy without the need for supervised titration is gaining popularity in the appropriate subset of patients.9 APAP was demonstrated to have equivalent effects on patient outcomes compared with the traditional in-laboratory titration approach.9,10
While the benefits of APAP therapy in OSA have been well documented,6–8 an overall effectiveness has been limited by poor adherence.11–15 Evidence suggests a continuous dose-response relationship between hours of use and therapeutic response16; however, PAP use for at least 4 hours per 24-hour period for 70% of prescribed days is commonly used to define the minimal acceptable level of adherence.17 Several factors can contribute to poor PAP adherence, including discomfort, inconvenience, and cost.13 A significant problem is discomfort associated with the PAP interface.12,15,18,19 Although significant progress has been made to improve PAP adherence by educational, behavioral, and technological methods, there is a continued need for strategies to improve and maintain adherence to PAP therapy.15,17 We examined the effect of a 30-minute sleep technician supervised and personalized APAP interface (mask) fitting session on adherence in patients likely to benefit from PAP therapy after home sleep testing.
METHODS
This was an efficacy study using a prospective randomized controlled trial design. The clinic population from which the patients were chosen was generally male and Caucasian with a median age in the mid-50s. The clinic is a referral sleep center, with patients coming from physician offices across the region that are affiliated with the health system.
Experimental protocol
Consecutive patients newly diagnosed with OSA and naive to treatment with PAP therapy were enrolled and prospectively randomized into 2 groups, group A and group B. Randomization was achieved by a computerized program, and patients were assigned to the 2 groups in the clinic according to this random scheme. Inclusion criteria consisted of patients above the age of 18 years diagnosed with OSA with cognitive and physical ability to safely and effectively undergo a sleep study at home. Patients were excluded from the study if they had any comorbid medical conditions that would degrade home sleep testing (Figure 1). A complete waiver of consent was approved by the Institutional Review Board to limit any behavioral bias in the primary endpoint being studied. Therefore, the patients were not aware that their APAP use was being studied.
Figure 1. Inclusion and exclusion criteria.
*Automatic positive airway pressure. +Continuous positive airway pressure. †Chronic obstructive pulmonary disease. ¥Left ventricular ejection fraction. APAP = automatic positive airway pressure, COPD = chronic obstructive sleep apnea, CPAP = continuous positive airway pressure, LVEF = left ventricular ejection fraction, NYHA = New York Heart Association, OSA = obstructive sleep apnea.
Patients were evaluated for OSA at an outpatient sleep clinic managed by board-certified sleep specialists. During the initial visit, medical history was obtained, and a physical exam was performed by a physician. Patients then underwent a baseline home sleep study to establish the presence of OSA. Those diagnosed with OSA returned to the clinic to be evaluated by the same physician and discuss treatment with APAP therapy. During this visit, the physicians provided the patients with information about the diagnosis of OSA and the treatment options. Those who qualified for PAP therapy were given a prescription for an APAP machine and related supplies, including the interface. Some patients were referred to the clinic after they had completed a sleep study and were already diagnosed with OSA. These patients underwent a modified visit combining the history and physical examination and discussion of treatment with APAP therapy into 1 visit. After patients received a prescription for an APAP machine and supplies, they were randomly assigned to either group A or group B by a medical assistant working at the clinic.
Group A consisted of the treatment arm where patients received a personalized APAP interface fitting session supervised by a sleep technician prior to starting home APAP therapy. Once randomized into group A, patients were brought in on a separate visit for a 30-minute APAP interface fitting session conducted and supervised by a certified sleep technician working at the clinic. The same sleep technician conducted the session for all patients in group A. During this session, patients were educated on how to effectively use the APAP machine. The different types, shapes, and sizes of APAP interfaces available for use were demonstrated to patients with the opportunity to try several interfaces with a running and connected APAP machine. During this session, patients were provided with strategies to overcome and troubleshoot any problem related to the APAP interface that they experienced during the session.
Group B served as the control arm where patients received the usual care and obtained an APAP interface directly through a durable medical equipment (DME) supplier. Patients’ experience with the DME vendor was variable, both between different vendors and within the same vendor depending on the personnel. Some personnel were continuous positive airway pressure (CPAP) technicians and some were respiratory therapists, but none were certified sleep technicians. The time spent with the patient varied from minutes to 1 hour. Mask charts were shown, and patients tried masks on with and without attachment to APAP. Patients themselves were the dominant deciding factor for the type of mask ultimately used. DME personnel had discussions with patients about the machines, reimbursement, and frequency of supplies.
After the patients obtained an APAP machine and the appropriate accessories, they proceeded to use it at home without supervision. Initial APAP pressures were set between 5 cm H2O and 20 cm H2O for all patients as this range is most commonly utilized in clinical practice. For patients in group A, there was ongoing support available over the phone or with a quick visit with the sleep technician if patients experienced any problems with APAP use during the initial 30 days of APAP use. Patients in group B were instructed to contact their DME vendor if they experienced any problems within the first 30 days. Per standard of care, all patients were asked to return to the clinic within 31–90 days for a follow-up appointment with the physician.
Instrumentation/equipment
Patient medical records, including age, sex, race, height, weight, body mass index, and baseline home sleep apnea test data consisting of the respiratory event index (REI) were abstracted from the outpatient clinic electronic medical record. The ResMed ApneaLinkhome sleep apnea test was utilized. Data regarding the clinical procedure outcomes such as total days of APAP usage, duration of APAP usage per day, amount of APAP interface air leak, and APAP pressure used were measured and recorded on a hard drive in the APAP machine. These data were subsequently uploaded onto the ResMed AirView program through which the data were accessed.
Data analysis
From an approximate baseline PAP usage rate of 50% extrapolated from prior studies15,16 and a hypothetical relative improvement of 28%, it was determined that a total of 130 (65 per group) patients would be needed to achieve at least 80% power to detect such an improvement as significant at P < .05. The power was established by comparing the primary endpoint, percent APAP usage, between the 2 groups by chi-square analysis.
The number of breathing events during the baseline home sleep study was used to determine the REI based on the American Academy of Sleep Medicine criteria for scoring respiratory events.20 An REI from 0 to < 5 per hour was considered normal, ≥ 5 to < 15 per hour was regarded as mild OSA, ≥ 15 to < 30 per hour was deemed moderate OSA, and severe OSA was diagnosed when REI was ≥ 30 per hour. The remaining data parameters that will be mentioned are collected and analyzed from the initial 30 days of APAP therapy. The means of the aggregate data were compared between the intervention (group A) and control (group B) groups. Percent APAP usage and APAP usage in days served as the primary endpoints. Percent APAP usage was calculated by taking the total number of days where patients used their APAP machine for ≥ 4 hours and dividing by 30 days. APAP usage in days was determined by counting the number of days patients used their APAP machine for any duration. A 30-day endpoint was chosen because it was previously shown that the pattern of PAP adherence is established in the early days of treatment.21–23 Furthermore, health insurance companies often use the initial 30-day period to determine coverage for APAP therapy based on adherence and require a face-to-face visit with a sleep physician after the initial 30 days.
Secondary endpoints included average duration of APAP usage per day, number of days APAP was used for ≥ 4 hours/day, rate of APAP interface air leak, threshold of 70% APAP adherence, and efficacy of APAP therapy based on average REI over initial 30 days. Differences in these parameters based on subgroups of age, sex, and OSA severity were also examined. Average duration of daily APAP use per number of days used was calculated in hours. The number of days the patients used the APAP machine for ≥ 4 hours per day was also determined. Air leaks related to APAP interface (recorded as L/min) and APAP pressure (recorded as cm H2O) were both averaged from the 95th percentile for each patient. The Centers for Medicare & Medicaid Services (CMS) threshold for APAP adherence, defined as APAP use ≥ 4 hours/day on 70% of the days, was evaluated, and the number of patients that met this threshold was compared between the 2 groups. The efficacy of APAP therapy was also compared between the 2 groups with means of the baseline REI and REI from the initial 30 days of APAP use. Three subgroups were analyzed with age (< 50 years old vs ≥ 50 years old), sex (male vs female), and OSA severity (mild, moderate, and severe). Means of percent APAP usage within each corresponding subgroup category were compared between group A and group B.
Statistical analysis
Descriptive statistics included means and standard deviations and frequencies and percentages. Bivariate statistics were used and included Student’s t-test and Pearson chi-square analysis, with significance of P < .05. The number of days used (overall adherence and among those with > 4 hours use) was compared between the 2 groups using the Mann-Whitney U test for nonparametric data. Average duration of daily use (mean days), APAP pressure (mean), and air leak (mean L/min) outcomes were compared between groups with the independent Student’s t-test. Target adherence (percent usage) by group was determined by chi-square analysis. A multiple regression analysis was conducted to predict group-related compliance adjusting for other demographic and clinical variables. The dependent variable was overall adherence and 70% adherence and the primary independent variable was group assignment, adjusted for the variables of age, sex, race, body mass index, and severity. A second model was conducted adjusting for interface air leak as a confirmatory check on the relationship of group assignment. Both were performed at a significance cutoff of .05 and an effect size of 15% or more.
RESULTS
Overall analysis
Patient enrollment began in January of 2019 and was completed later that year in September. A total of 156 patients were prospectively randomized for the study with 18 (11.5%) patients excluded, 11 from group A and 7 from group B. Twelve out of the 18 either declined or did not pursue treatment prior to initiation of APAP therapy and 6 did not meet criteria (Figure 2). A total of 138 (88.5%) were included in the analysis. The mean age was 56.5 years (SD = 13.0). Men comprised 78 (56.5%) and women 60 (43.5%). The majority were Caucasian (n = 116 or 84%) with 9 (6.5%) African American, 2 (1.4%) Hispanic, and 1 (0.7%) Native American. Additionally, 10 patients did not identify their race. The average body mass index was 34.2 (SD = 6.2) and the average REI at baseline was 23.4 (SD = 15.7).
Figure 2. Experimental protocol, attrition, and significant clinical procedure outcomes.
A visual breakdown of each group in the study including reason for exclusion after participants were randomized and clinical outcomes between the 2 groups. *OSA. †Group A = intervention group with 30-minute sleep technician supervised APAP interface fitting. ¥Group B = control group. +APAP. APAP = automatic positive airway pressure, OSA = obstructive sleep apnea.
The majority of patients were diagnosed with moderate OSA (n = 57, 41%) while 45 (33%) had mild OSA and 36 (26%) had severe OSA. The overall percent APAP usage was 73.1% (SD = 30.4) and APAP usage during the initial 30 days was an average of 25.7 days (SD = 7.4) with duration of daily usage averaging 5.8 hours (SD = 2.0) per days used. Among patients using the APAP machine 4 hours or more per day, the average days of use for the total group was 22 days (SD = 9.1). APAP interface air leaks occurred at an average of 18.0 L/min (SD = 17.0), and average APAP pressure was 11.8 cm H2O (SD = 2.8). Out of 138 patients, 101 (73%) achieved the goal APAP adherence of 70%.
Group analysis
Sixty-eight (49%) patients were assigned to group A, which was the intervention group and 70 (51%) assigned to group B, the control group. The 2 groups were similar in all demographic and baseline characteristics (Table 1). During the initial 30 days of APAP therapy, patients in group A used the APAP machine on more days compared to group B (27 vs 24 days; P = .01). This represents a relative 11% magnitude difference in usage between the groups. Although the average duration of daily APAP usage per days used in each group was similar, among patients who used their APAP machine ≥ 4 hours per day, the number of days of usage was greater among group A compared to group B (23.5 vs 20.4 days; P = .04). The amount of air leak present at the APAP interface was significantly lower in group A compared to group B (14.9 vs 21.1 L/min; P = .03). The APAP pressure did not differ by group (11.7 vs 11.9 cm H2O; P = .68). Patients in group A were more adherent to APAP therapy, with higher percent APAP usage (78.4% vs 67.8%; P = .04) compared to group B. The target APAP adherence as defined by CMS (APAP use ≥ 4 hours/day on 70% of the days) was achieved by more patients in group A compared to group B (54 [79%] vs 47 [68%]). A relative 15% difference was observed but was not significant at P = .10. Refer to Table 2 for summary of clinical procedure outcomes data by treatment group. Although APAP usage in group A was higher compared to group B, residual REI during initial 30 days of APAP use was not different between the 2 groups (Table 3).
Table 1.
Demographic and clinical descriptive characteristics by treatment group.
| Group A (n = 68) | Group B (n = 70) | P | |
|---|---|---|---|
| Age, y (mean [SD]) | 56.9 (12.8) | 56.1 (13.3) | .99 |
| Sex (%) | |||
| Males | 36 (53) | 42 (60) | |
| Females | 32 (47) | 28 (40) | .21 |
| Race (%) | |||
| Caucasian | 57 (84) | 59 (84) | |
| Other | 11 (16) | 11 (16) | 1.0 |
| BMI, mean (SD) | 33.7 (5.9) | 34.6 (6.5) | .40 |
| Baseline REI, mean (SD) | 23.8 (15.0) | 23.0 (16.5) | .77 |
| OSA severity, mean (%) | |||
| Mild | 20 (29) | 25 (36) | |
| Moderate | 31 (46) | 26 (37) | |
| Severe | 17 (25) | 19 (27) | .57 |
Side-by-side comparison of demographic and descriptive characteristics between groups. BMI = body mass index, OSA = obstructive sleep apnea, REI = respiratory event index, SD = standard deviation.
Table 2.
Clinical procedure outcomes by treatment group.
| Group A (n = 68) | Group B (n = 70) | P | |
|---|---|---|---|
| Percent APAP usage (%), mean (SD) | 78.4 (25.8) | 67.8 (33.6) | .04* |
| APAP usage over 30 d (d), mean (SD) | 27.0 (5.6) | 24.0 (8.6) | .01* |
| APAP usage/day/days used (h), mean (SD) | 5.9 (1.7) | 5.6 (2.2) | .49 |
| APAP usage ≥ 4 h/d (d), mean (SD) | 23.5 (7.7) | 20.4 (10.1) | .04* |
| APAP interface air leak (L/min), mean (SD) | 14.9 (11.1) | 21.1 (20.1) | .03* |
| APAP pressure (cm H2O), mean (SD) | 11.7 (2.6) | 11.9 (3.1) | .68 |
| ≥70% APAP adherence (%) | 54 (79) | 47 (67) | .10 |
Side-by-side comparison of clinical procedure outcomes between the two groups. *Significant difference exists between groups. APAP = automatic positive airway pressure, SD = standard deviation.
Table 3.
Mean REI prior to (baseline) and during APAP therapy (30-day average).
| Group A (n = 68) | Group B (n = 70) | P | |
|---|---|---|---|
| Baseline REI, mean (SD) | 23.8 (15.013) | 23.0 (16.5) | .76 |
| Average REI during APAP use, mean (SD) | 4.0 (4.8) | 4.9 (5.3) | .29 |
Side-by-side comparison of the mean REI scores between the groups at baseline and during APAP therapy. APAP = automatic positive airway pressure, REI = respiratory event index, SD = standard deviation.
Group assignment was a significant independent predictor of greater overall compliance when adjusting for and holding constant the other demographic and clinical variables (β = –0.19, t = −2.2, P = .03). The second outcome analysis showed group assignment to trend toward being a significant independent predictor of greater 70% compliance (β = −0.15, t = −1.7, P = .07). The model was rerun adjusting for leakage. Group assignment (P = .05) and leakage (P = .04) were trending as independent significant predictors of overall compliance (β = −0.13, t = −1.5, P = .06). Group assignment (P = .10) and leakage (P = .11) were not significant predictors of 70% compliance adjusting for the other variables (β = −0.13, t = −1.5, P = .14).
Subgroup analysis
Percent APAP usage was significantly higher among patients ≥ 50 years old in group A compared to group B (83.0% vs 73.1%; P = .05). In contrast, percent APAP usage in patients < 50 years old was not different between groups. Female patients in group A tended to be more adherent to APAP therapy compared to group B based on percent APAP usage (80.8% vs 61.4%; P = .06). No difference in APAP usage was noted between groups among male patients. When separated by OSA severity, patients in group A with moderate OSA were found to have significantly higher percent APAP usage compared to those in group B (86.6% vs 72.2%; P = .03) while there was no difference between groups in patients with mild and severe OSA. Refer to Table 4 for summary of percent APAP usage data of subgroups.
Table 4.
Percent APAP usage of subgroups by treatment group.
| Percent APAP Usage by subgroups (%) | Group A (n = 68) | Group B (n = 70) | P |
|---|---|---|---|
| Age, mean (SD) | |||
| < 50 y | 70.0 (28.2), n = 23 | 61.0 (36.6), n = 22 | .36 |
| ≥ 50 y | 83.0 (23.5), n = 45 | 71.1 (32.0), n = 48 | .05* |
| Sex, mean (SD) | |||
| Male | 76.3 (25.8), n = 36 | 72.1 (31.7), n = 42 | .53 |
| Female | 80.8 (25.9), n = 32 | 61.4 (36.0), n = 28 | .06+ |
| OSA severity, mean (SD) | |||
| Mild | 70.8 (30.4), n = 20 | 58.3 (36.7), n = 25 | .23 |
| Moderate | 86.6 (15.8), n = 31 | 72.2 (31.1), n = 26 | .03* |
| Severe | 72.5 (31.2), n = 17 | 74.6 (31.4), n = 19 | .85 |
Side-by-side comparison of percent APAP usage of subgroups comparing the 2 groups. *Significant difference exists between groups. +There is a trend toward a significant difference between groups. APAP = automatic positive airway pressure, OSA = obstructive sleep apnea, SD = standard deviation.
DISCUSSION
PAP therapy results in a clinically significant reduction in disease severity of OSA. It is recommended as an initial treatment for patients with moderate to severe OSA. More patients are being diagnosed based on home sleep testing. APAP therapy has been shown to have equivalent effects compared to in-laboratory supervised titration approach.9,10 Poor adherence is a major barrier to maximizing the effectiveness of PAP therapy. Previous studies estimated adherence to PAP therapy to range from 30% to 60%.14,15 Technological advances in PAP therapy have been developed to promote patient comfort and potentially improve adherence to treatment. Device improvement has only had a modest impact on adherence.24 More attention has been given to educational and behavioral interventions to improve patient adherence.25 Clinical trials have demonstrated suboptimal group adherence ranging from 3 to 5 hours per night.26 These findings demonstrate that there is a continued need to evaluate strategies to improve and maintain PAP adherence.
Evidence suggests that adherence patterns of PAP usage are established in the early days of treatment and this pattern is maintained long-term.21–23 One study showed that an adherence pattern can be established within 2 to 4 days of treatment onset.27 Furthermore, it was previously demonstrated that the degree of improvement in quality of sleep during the initial PAP titration correlates with increased adherence rate on a nightly basis.21 These findings indicate that the initial experience of PAP therapy is incredibly important in determining subsequent use. Therefore, any interventions to improve PAP adherence would likely have the greatest impact if implemented early.
In this prospective randomized study, a dedicated sleep technician supervised interface fitting session prior to onset of APAP therapy improved APAP usage when compared to usual care. The intervention group used APAP on an average of 27 days (± 5.6) in 30 days, vs 24 (± 8.6) days in the control group (P = .01). Percent APAP usage in the intervention group was 74.8% vs 67.8% in the control group (P = .04) (Table 2). Patients on average used APAP 3 days more per 30 days with 3 more days over 4 hours per day in 30 days. This was evident in both primary endpoints with percent APAP usage as well as APAP usage in days. The combination of early education and simulated experience likely equipped the patients with a better understanding and strategies to troubleshoot any problems during treatment, thus leading to higher adherence. Interface air leaks are common adverse effects of PAP therapy and have been attributed to poor adherence.28, 29 Air leaks can lead to discomfort, dryness, and increased machine noise that can disturb sleep for both patients and their partners. There is no established consensus to discriminate between tolerable air leak and leak that requires correction.30 In our study, average interface air leak was significantly lower in the treatment group compared to the control group (14.9 vs 21.1 L/min, P = .03) (Table 2). This reduction in air leak was not due to the level of pressure used, which was similar in both groups (11.7 cm H2O vs 11.9 cm H2O). It was likely due to appropriate interface fitting.
Patients in the treatment group used APAP for ≥ 4 hours on more days compared to usual care, and there was a trend toward reaching the commonly accepted and designated threshold of reaching 70% adherence that health insurance companies use to make decisions regarding cost coverage for APAP therapy. In general, home APAP therapy is covered by health insurance companies if the patient is deemed to be adherent during the initial 31 to 90 days of APAP use based on the CMS definition for APAP adherence. If therapy is not covered by health insurance, patients are at risk of discontinuing the treatment altogether.
On post hoc subgroup analysis, patients with moderate OSA (the majority in this study) in the treatment group used the APAP more compared to those in the control group (percent APAP usage 86.1% vs 72.2%, P = .003). It could be that these patients experienced the most improvement in quality of sleep, which motivated them to be more adherent. Patients over the age of 50 years in the treatment group achieved higher percent APAP usage compared to the control group (83% vs 71.1%, P = .05). Female patients in the treatment group had better adherence compared to females in the control group (84.3% vs 69.5%, P = .01). Although sex-related differences have been seldom studied and less clear,31 it has been shown that increasing age correlates with higher adherence.32 Our findings indicate that older and female patients with moderate OSA are more likely to be receptive to and benefit from an interface fitting session prior to starting home APAP therapy.
Previously, in-laboratory polysomnography and PAP titration were done in the sleep lab, supervised by qualified sleep technicians. During the diagnostic and treatment session, direct communication with patients about technical and educational issues is usually done. However, with the proliferation of home sleep testing and the acceptance of APAP as equivalent to supervised CPAP titration, there is no direct communication between patients and qualified sleep personnel regarding the technical aspects and interface fitting. With APAP therapy, the delivery of the machine as well as the appropriateness of interface fitting is usually left to the DME supplier. This may be done by qualified or nonqualified personnel. APAP interface is a common impediment to the use of PAP therapy due to poor fit; air leaks; interface dislocation; discomfort; skin irritation; patient-related problems such as anxiety, claustrophobia, PTSD, and other psychiatric problems; and other factors. Interface air leak can lead to excessive noise, bloating, and mucosal dryness, ultimately leading to poor adherence with APAP therapy.
We chose to examine the first 30 days after initiation of APAP therapy, because it was previously shown that a pattern of PAP adherence is established in the early days of treatment and maintained long term.24–26 Furthermore, most health insurance companies require face to face visit with a sleep physician after initial 30 days to ensure efficacy and adherence. Lack of adherence based on the CMS definition can lead to denial of insurance coverage for the APAP. One study showed that PAP adherence patterns can be established within 2–4 days of treatment.27 It was previously demonstrated that the degree of improvement in quality of sleep during the initial PAP titration correlates with increased adherence rate on a nightly basis.21 These findings suggest that the initial experience of APAP is important in determining subsequent use and any intervention to improve PAP therapy would likely have the greatest impact if implemented early.
In 2008, Krakow et al33 introduced PAP-nap as a beneficial approach to desensitize patients with OSA to PAP therapy. PAP-nap is an intervention that is typically done in the sleep lab with appropriate fitting of the PAP equipment and coaching by a sleep technician to ensure a comfortable experience with PAP therapy for the patient. It usually lasts 35 hours, with 1–3 hours of sleep time. In the study by Krakow et al,33 PAP-nap was used for patients with moderate to severe OSA who also had insomnia as well as psychiatric disorders or symptoms. The PAP-nap group was compared to a control group with similar characteristics and fared better in completing PAP titrations, filling prescriptions for PAP therapy, and adhering to PAP therapy.33 CPT code 95807-52 was used for reimbursement.33 In our study, we used CPT 94660 (CPAP initiation and management for patients visiting primarily due to issues related to PAP treatment and management of sleep disorder). The service in our study was provided by a certified sleep technician in an outpatient clinic under the supervision of a sleep physician. CPT code 94660 cannot be billed with evaluation and management at the same time. The service usually takes 30 minutes in the office, with direct interaction between sleep technician and patient. A relationship is established between 2 parties for future problems. Our study demonstrated that this service is effective in increasing adherence and improving comfort. It is cost-effective, covered under most health insurance plans, and is more convenient for patients overall.
The strength of this study is the relatively large number of patients randomized in a specialty sleep clinic. All patients had no prior exposure to or experience with PAP therapy, limiting any prior bias. Multiple DME companies in the area were used as control. The service provided to the treatment group is covered by health insurance. Limitations include the single-center study design and the relatively short follow-up period. This may have impacted the final modeling to be slightly underpowered at the resulting effect size of 10% difference. Another limitation is that the providers in the control group were heterogeneous in qualifications and experience. The study may not be generalizable to all sleep clinics and practices. The short 30-day follow-up may be a limitation, as APAP adherence may decrease with long-term follow-up. However, the first week of PAP use was previously shown to be the strongest predictor of subsequent use.32
In conclusion, in patients diagnosed with OSA by home sleep testing and requiring APAP therapy, a dedicated 30-minute interface fitting session with an experienced sleep technician is an inexpensive intervention that is easy to implement but can have a significant impact on patient adherence. It affords APAP users the benefits of a simulated experience without the inconvenience and extra cost of completing a full night sleep study in a sleep laboratory. It improves adherence, comfort, and reduces interface air leaks. Older (age > 50) and female patients with moderate OSA seem to benefit the most with this intervention. Further studies are needed to confirm these findings and to study the long-term benefit.
DISCLOSURE STATEMENT
All authors have seen and approved this manuscript. Work for this study was performed at Genesee Lung Associates. Fahim Khorfan is an employee of the sleep clinic where the study was conducted. He received no direct benefit or sponsorship. None of the other authors report conflicts of interest.
ACKNOWLEDGMENTS
The authors thank all the physicians and staff at Genesee Lung Associates, all of the study participants, and Patricia Mitchell for their assistance in this study.
ABBREVIATIONS
- APAP,
automatic positive airway pressure
- CMS,
Centers for Medicare & Medicaid Services
- CPAP,
continuous positive airway pressure
- DME,
durable medical equipment
- OSA,
obstructive sleep apnea
- PAP,
positive airway pressure
- REI,
respiratory event index
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