ABSTRACT
Objectives
Hypoglossal nerve stimulation (HNS) has emerged as a treatment for obstructive sleep apnea (OSA). While current literature suggests comorbid nasal pathology can decrease quality of life (QoL) in OSA populations, its impact on HNS efficacy has been less explored. This study assesses whether the presence of nasal pathology changes HNS efficacy in improving sleep outcomes in OSA patients.
Methods
A retrospective analysis evaluated 90 patients who underwent HNS implantation. Treatment efficacy and QoL were assessed preoperatively and postoperatively with apnea–hypopnea index (AHI), Epworth sleepiness scale (ESS), and functional outcomes of sleep questionnaire (FOSQ‐10). Nasal exam and nasopharyngoscopy findings derived four groups: normal nasal findings (n = 44), positive anterior rhinoscopy findings (n = 32), positive nasopharyngoscopy findings (n = 36), and any positive nasal finding (n = 46). Septal deviation, septal perforation, polyps, masses, vestibular stenosis, and turbinate hypertrophy were considered positive findings. Outcomes within and across groups were analyzed using t‐tests, Mann–Whitney U‐tests, and Wilcoxon signed‐rank tests.
Results
Both AHI and ESS scores significantly improved across all groups (p < 0.05) following HNS. FOSQ‐10 in patients with positive anterior rhinoscopy findings did not significantly improve. Average FOSQ‐10 improvement was significantly greater in the control group compared to the positive anterior rhinoscopy findings (p < 0.05). All groups met Sher15 and Sher20 criteria at similar rates.
Conclusions
Comorbid nasal pathology does not diminish the effectiveness of HNS in treating OSA, with all groups showing significant improvement in AHI and ESS scores. However, impacts on broader QoL, measured by FOSQ‐10, warrant further investigation.
Level of Evidence
3.
Keywords: AHI, FOSQ‐10, hypoglossal nerve stimulation, nasal pathology, obstructive sleep apnea
Hypoglossal nerve stimulation (HNS) is a surgical treatment for patients with obstructive sleep apnea (OSA) who cannot tolerate continuous positive airway pressure. Comorbid nasal pathology, such as septal deviations, turbinate hypertrophy, polyps, vestibular stenosis, and masses, is frequently seen and has been shown to decrease quality of life in patients with OSA, but nasal pathology has not been evaluated in the context of HNS treatment. Nasal pathology has no effect on objective measures of OSA, but may affect subjective quality of life outcomes in patients who undergo HNS.
1. Introduction
Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway collapse during sleep, leading to disrupted sleep and intermittent hypoxia [1]. Untreated OSA leads to associated health issues like cardiovascular disease, cognitive impairment, and decreased health‐related quality of life (QoL) [2, 3, 4]. The current gold standard and primary treatment for OSA remain continuous positive airway pressure (CPAP). However, a significant proportion of patients are unable or unwilling to adhere to this therapy either due to discomfort, intolerance, or other reasons [5, 6, 7, 8, 9]. An alternative intervention that has emerged is hypoglossal nerve stimulation (HNS), particularly in patients with moderate to severe OSA who are CPAP‐intolerant [10].
HNS activates the genioglossus muscle via the stimulation of the hypoglossal nerve, resulting in airway enlargement at the level of the palate and tongue base [11]. The Inspire device is the first and only US Food and Drug Administration (FDA) approved HNS system. This device utilizes a respiratory sensing lead and a stimulation lead to provide respiratory synchronized stimulation of the hypoglossal nerve [12]. Clinical trials such as the STAR trial have illustrated the benefits of improving both objective measures like apnea–hypopnea index (AHI) and subjective measures like the Epworth sleepiness scale (ESS) and functional outcomes of sleep questionnaire (FOSQ) [13]. This makes HNS a promising alternative for patients with moderate to severe OSA who struggle with CPAP therapy.
Sinonasal pathology (i.e., septal deviation, turbinate hypertrophy, and chronic rhinosinusitis) is frequently observed and self‐reported in patients with OSA [14]. It has been shown that patients with nasal obstruction or nasal pathology concurrent with OSA have lower compliance with CPAP, and worse ESS and FOSQ scores [15]. One study illustrated that high nasal airway resistance in patients with allergic rhinitis can lead to longer OSAs [16]. Nasal surgery has been illustrated to improve ESS in patients with nasal pathology and OSA [17]. Despite the common occurrence of nasal pathology and OSA, the impact of these nasal conditions on the effectiveness of HNS has not been thoroughly investigated. This study seeks to address this gap in the literature by evaluating whether the presence of nasal pathology alters both the objective and subjective efficacy of treating OSA.
2. Methods
A retrospective analysis was conducted on 90 patients who underwent HNS by a single surgeon at a single institution. This study was approved by the Virginia Commonwealth University Institutional Review Board (IRB #HM2002304). Treatment efficacy and QoL were assessed both preoperatively and postoperatively with AHI, ESS, and FOSQ‐10. For each patient, information regarding prior nasal surgery, history of rhinitis and/or sinusitis, subjective nasal obstruction symptoms, and relevant medical treatments for nasal conditions at the time of their initial sleep surgery clinic visit was documented. Preoperative ESS and FOSQ‐10 values were recorded from the most recent visit available prior to HNS. Postoperative ESS and FOSQ‐10 values were recorded at the first follow‐up after device activation. Patients with no ESS and FOSQ documentation at their first follow‐up after HNS activation were excluded. To ensure consistency, only patients with matching preoperative and postoperative AHI oxygen desaturation percentage criteria were included. Preoperative AHI was the most recent sleep study done prior to HNS, and the postoperative AHI was the first sleep study done after activation. Patient age and BMI at the time of surgery were also recorded.
Inclusion criteria also required patients to have a documented anterior rhinoscopy on nasal exam and a nasopharyngoscopy before the surgery. All patients presenting to the sleep surgery clinic for evaluation of HNS eligibility undergo an anterior rhinoscopy and nasopharyngoscopy. These were all done by the same surgeon who implanted the HNS device for all patients. Based on these findings, patients were categorized into four groups: those with normal nasal findings (n = 44), those with positive nasal exam findings on anterior rhinoscopy (n = 32), those with positive findings on nasopharyngoscopy (n = 36), and those with any positive nasal finding (n = 46). Positive nasal findings constituted any abnormal anatomy, such as septal deviation, turbinate hypertrophy, septal perforations, polyps, masses, and vestibule stenosis. These are clinically defined without specific scales. Notably, patients with a documented finding of only “slight septal deviation” were included in the “normal nasal findings” group. Given the nature of this data, some patients are represented in multiple categories due to overlapping findings (i.e., a patient has a positive anterior rhinoscopy and a positive nasopharyngoscopy). This overlap is depicted in Figure 1.
FIGURE 1.
Overlap of positive nasal pathology findings in patients prior to undergoing hypoglossal nerve stimulation. The Venn diagram illustrates the distribution of patients within each of the three cohorts. The positive anterior rhinoscopy findings cohort consists of 32 patients (i.e., 10 + 22), the positive nasopharyngoscopy findings cohort consists of 36 patients, and the positive nasal findings cohort consists of 46 patients.
Baseline age and BMI were compared between groups using analysis of variance (ANOVA). The Shapiro–Wilk test assessed the normality of pre‐HNS values, post‐HNS values, and change before and after HNS for AHI, ESS, and FOSQ‐10. Paired two‐tailed t‐tests were used to evaluate pre‐HNS and post‐HNS changes for groups with normally distributed data. For groups where the Shapiro–Wilk test indicated non‐normal distribution, Wilcoxon signed‐rank tests were used. Unpaired t‐tests were used to evaluate the change in AHI, ESS, and FOSQ‐10 between groups with normally distributed data. For groups where Shapiro–Wilk testing indicated non‐normal distribution, Mann–Whitney U‐tests were used. Levene's test was used to confirm normal variance in changes in AHI, ESS, and FOSQ‐10 before and after HNS. Sher15 and Sher20 criteria were analyzed across groups using Fisher's exact test. Individual questions within the FOSQ‐10 questionnaire were further analyzed between and across groups using t‐tests.
3. Results
The average age at HNS implantation was 63.89 ± 10.99 years, and the average BMI was 29.00 ± 3.12 kg/m2. The one‐way ANOVA revealed no statistically significant differences between groups for age (F (3, 154) = 1.29, p = 0.282) or BMI (F (3, 154) = 0.63, p = 0.595). The mean age and BMI stratified by group are shown in Table 1, along with other pre‐HNS and post‐HNS characteristics.
TABLE 1.
Patient characteristics pre‐HNS implantation and post‐HNS implantation for each cohort.
| Normal nasal exam (n = 44) | Positive anterior rhinoscopy findings (n = 32) | Positive nasopharyngoscopy findings (n = 36) | Any positive nasal findings (n = 46) | |||||
|---|---|---|---|---|---|---|---|---|
| p | p | p | ||||||
| Pre‐HNS | ||||||||
| Age, years | 65.6 ± 9.3 | 60.8 ± 12.3 | 61.4 ± 12.4 | 62.4 ± 12.3 | ||||
| BMI, kg/m2 | 28.6 ± 3.0 | 29.4 ± 3.4 | 29.3 ± 3.0 | 29.4 ± 3.2 | ||||
| AHI, events/h | 33.7 | 31.0 | 29.8 | 30.9 | ||||
| ESS a | 9.2 | 9.5 | 9.5 | 9.7 | ||||
| FOSQ‐10 b | 30.3 | 31.4 | 31.2 | 31.5 | ||||
| Post‐HNS | ||||||||
| AHI, events/h | 13.5 | 11.3 | 10.2 | 10.7 | ||||
| ∆AHI, events/h c | −20.2 | −19.7 | 0.792 | −19.6 | 0.834 | −20.2 | 0.999 | |
| ESS a | 6.6 | 6.4 | 6.8 | 6.7 | ||||
| ∆ESS c | −2.6 | −3.1 | 0.595 | −2.7 | 0.841* | −2.9 | 0.873* | |
| FOSQ‐10 b | 34.3 | 32.3 | 33.1 | 33.0 | ||||
| ∆FOSQ‐10 c | 4.0 | 0.9 | 0.025* | 2.0 | 0.230* | 1.5 | 0.061* | |
Note: p values are compared with groups to the normal nasal exam cohort using Mann–Whitney U‐test (*) or unpaired t‐tests, with bold text signifying less than 0.05.
Abbreviations: AHI, apnea–hypopnea index; BMI, body mass index; ESS, Epworth sleepiness scale; FOSQ‐10, functional outcomes of sleep questionnaire; HNS, hypoglossal nerve stimulation.
ESS scores range from 0 to 24, with higher scores indicating more daytime sleepiness.
FOSQ‐10 scores range from 10 to 40, with higher scores indicating better sleep‐related quality of life.
Change from Pre‐HNS.
The Shapiro–Wilk test was significant (p < 0.05) for all pre‐HNS and post‐HNS AHI values. Wilcoxon signed‐ranked tests evaluating AHI values before and after HNS implantation showed significant improvements across all four groups: normal nasal findings (p < 0.001), positive anterior rhinoscopy findings (p < 0.001), positive nasopharyngoscopy findings (p < 0.001), and any nasal finding (p < 0.001). The average change in AHI for each group was −20.22 ± 12.67 events/h for normal nasal findings, −19.66 ± 17.99 events/h for positive anterior rhinoscopy findings, −19.57 ± 14.83 events/h for positive nasopharyngoscopy findings, and −20.22 ± 16.73 events/h for any positive nasal finding. There were no significant differences in the magnitude of AHI change between groups, as unpaired, two‐tailed t‐tests compared with AHI changes between groups resulted in p values of: 0.792 for normal nasal findings vs. positive anterior rhinoscopy findings, 0.834 for normal nasal findings vs. positive nasopharyngoscopy findings, and 0.999 for normal nasal findings vs. any positive nasal finding. The Shapiro–Wilk test confirmed the normality of AHI differences across all groups (p > 0.05), and Levene's test showed no significant differences in the variance of AHI changes between groups (p = 0.996).
All AHI values were calculated from single amplitude sleep studies or titration polysomnography (PSG). In the normal nasal findings group, 40.91% were titration PSG studies, and 59.10% were single amplitude studies. The positive anterior rhinoscopy findings group was 59.38% titration PSG studies and 40.63% single amplitude studies. The positive nasopharyngoscopy findings group was 61.11% titration PSG studies and 38.89% single amplitude studies. The positive nasal findings group was 58.70% titration PSG studies and 41.30% single amplitude studies.
The Shapiro–Wilk test was significant (p < 0.05) for pre‐HNS and post‐HNS ESS values in the positive nasopharyngoscopy findings and any nasal findings groups. Paired two‐tailed t‐tests and Wilcoxon signed‐rank tests evaluating ESS values before and after HNS implantation showed significant improvement across all groups (p < 0.001). The average change in ESS for each group was −2.57 ± 4.43 for normal nasal findings, −3.11 ± 4.28 for positive anterior rhinoscopy findings, −2.71 ± 4.39 for positive nasopharyngoscopy findings, and −2.92 ± 4.17 for any positive nasal findings. Shapiro–Wilk tests indicated normal distribution in ESS changes for normal nasal findings (p = 0.3516) and positive anterior rhinoscopy findings (p = 0.0718). The positive nasopharyngoscopy findings (p = 0.01696) and any positive nasal finding (p = 0.03831) did not meet the normality assumption. There were no significant differences in the magnitude of ESS change between the groups, as unpaired two‐tailed t‐tests and Mann–Whitney U‐tests compared with ESS changes between groups resulted in p values of: 0.595 for normal nasal findings vs. positive anterior rhinoscopy findings, 0.841 for normal nasal findings vs. positive nasopharyngoscopy findings, and 0.873 for normal nasal findings vs. any positive nasal findings. Levene's test showed equal ESS variance between groups (p = 0.996).
The Shapiro–Wilk test was significant (p < 0.05) for all pre‐HNS and post‐HNS FOSQ‐10 values. Wilcoxon signed‐rank tests evaluating FOSQ‐10 values before and after HNS implantation showed significant improvement in the following three groups: normal nasal findings (p < 0.001), positive nasopharyngoscopy findings (p < 0.001), and any nasal finding (p = 0.016). There was no significant improvement in FOSQ‐10 scores before and after HNS implantation in the positive anterior rhinoscopy findings group (p = 0.119). The Shapiro–Wilk test indicated non‐normal distribution for FOSQ‐10 changes in all groups (p < 0.05) except for the positive anterior rhinoscopy findings group (p = 0.223). Mann–Whitney U‐tests showed greater FOSQ‐10 improvement in the control group compared to the positive anterior rhinoscopy findings (p = 0.025), but no significant difference when compared with the normal nasal findings group to the positive nasopharyngoscopy findings group (p = 0.230) or any positive nasal findings group (p = 0.061). Table 2 summarizes all p values for pre‐AHI and post‐AHI, ESS, and FOSQ‐10 changes.
TABLE 2.
p values of pre‐HNS and post‐HNS paired t‐tests showing changes in AHI, ESS, and FOSQ‐10 within patient cohorts.
| Normal nasal findings (n = 44) | Positive anterior rhinoscopy findings (n = 32) | Positive nasopharyngoscopy findings (n = 36) | Any positive nasal findings (n = 46) | |
|---|---|---|---|---|
| AHI | < 0.001 | < 0.001* | < 0.001* | < 0.001* |
| ESS | < 0.001 | < 0.001* | < 0.001* | < 0.001* |
| FOSQ | < 0.001* | 0.119* | 0.008* | 0.016* |
Note: p values are compared with each individual patient's post‐HNS and pre‐HNS scores using Wilcoxon signed‐rank tests (*) or paired t‐tests, with bold text signifying less than 0.05.
Abbreviations: AHI, apnea–hypopnea index; BMI, body mass index; ESS, Epworth sleepiness scale; FOSQ‐10, functional outcomes of sleep questionnaire; HNS, hypoglossal nerve stimulation.
FOSQ‐10 questions were further analyzed in the normal nasal finding, positive anterior rhinoscopy findings, and any positive nasal finding groups using unpaired, two‐tailed t‐tests. Average improvement to questions 2, 6, and 8 was significantly greater in the control group compared to the positive anterior rhinoscopy findings (p < 0.05). Average improvement to questions 6 and 8 was significantly greater in the control group compared to any positive nasal findings group (p < 0.05). All other questions had no significant average improvement when compared to the normal nasal findings group. These results can be seen in Table 3.
TABLE 3.
Comparison of average change in individual FOSQ‐10 questions.
| Normal nasal findings vs. positive anterior rhinoscopy findings, p | Normal nasal findings vs. any positive nasal findings, p | ||
|---|---|---|---|
| Q1 | Do you have difficulty concentrating on things you do because you are sleepy or tired? | 0.0629 | 0.1570 |
| Q2 | Do you generally have difficulty remembering things because you are sleepy or tired? | 0.0481 | 0.2370 |
| Q3 | Do you have difficulty operating a motor vehicle for short distances (less than 100 miles) because you become sleepy? | 0.0863 | 0.0828 |
| Q4 | Do you have difficulty operating a motor vehicle for long distances (greater than 100 miles) because you become sleepy? | 0.2038 | 0.1710 |
| Q5 | Do you have difficulty visiting your family or friends in their home because you become sleepy or tired? | 0.1846 | 0.2713 |
| Q6 | Has your relationship with family, friends, or work colleagues been affected because you are sleepy or tired? | 0.0300 | 0.0450 |
| Q7 | Do you have difficulty watching a movie or video because you become sleepy or tired? | 0.6647 | 0.6702 |
| Q8 | Do you have difficulty being as active as you want to be in the evening because you are sleepy or tired? | 0.0366 | 0.0404 |
| Q9 | Do you have difficulty being as active as you want to be in the morning because you are sleepy or tired? | 0.3673 | 0.3739 |
| Q10 | Has your mood been affected because you are sleepy or tired? | 0.2672 | 0.6454 |
Note: p values are calculated using an unpaired, two‐tailed t‐test, with bold text signifying p < 0.05.
Abbreviation: FOSQ‐10, functional outcomes of sleep questionnaire.
Evaluation of Sher15 and Sher20 criteria using Fisher's exact test showed no significant difference between groups (p > 0.05), which is illustrated in Table 4.
TABLE 4.
Patients meeting Sher15 or Sher20 criteria.
| Yes | No | p | ||
|---|---|---|---|---|
| Meeting Sher15 criteria a | ||||
| Normal nasal findings | 29 | 15 | ||
| Positive anterior rhinoscopy findings | 20 | 12 | 0.811 | |
| Positive nasopharyngoscopy findings | 23 | 13 | 1.000 | |
| Any nasal findings | 30 | 16 | 1.000 | |
| Meeting Sher20 criteria b | ||||
| Normal nasal findings | 31 | 13 | ||
| Positive anterior rhinoscopy findings | 21 | 11 | 0.8052 | |
| Positive nasopharyngoscopy findings | 26 | 10 | 1.000 | |
| Any nasal findings | 33 | 13 | 1.000 |
Note: p values are calculated using a Fisher's exact test and compared to the normal nasal findings group.
Criteria met if patient's apnea–hypopnea index (AHI) is reduced by 50% or more and the postoperative AHI is below 15 events/h.
Criteria met if the patient's AHI is reduced by 50% or more and the postoperative AHI is below 20 events/h.
A wide spectrum of nasal pathologies was observed among patients with positive findings (Table 5). The most common finding was septal deviation, present in 35 patients (76.10%), with 20 of those having some concurrent nasal finding. Table 6 summarizes the prevalence of past nasal surgery, rhinitis and/or sinusitis diagnosis, subjective nasal obstruction symptoms, and medical management of nasal obstruction. Nasal obstruction diagnosis was significantly higher in all positive nasal pathology groups, but subjective nasal obstruction was only significantly higher in the positive anterior rhinoscopy findings group.
TABLE 5.
Prevalence of nasal pathology seen in patients with positive nasal pathology (n = 46).
| Finding | Prevalence (n) | Percentage (%) | Concurrent pathologies |
|---|---|---|---|
| Septal deviation | 35 | 76.10 | 20 |
| Turbinate hypertrophy | 16 | 34.78 | 13 |
| Nasal polyps | 2 | 4.35 | 1 |
| Significant crusting/scarring/scabbing | 4 | 8.70 | 3 |
| Septal perforation | 2 | 4.35 | 2 |
| Septal spur | 8 | 17.39 | 6 |
| Vestibular stenosis | 5 | 10.87 | 5 |
| Other | 1 | 2.17 | 0 |
Note: Concurrent pathologies can be any of the other findings listed in this table.
TABLE 6.
Patient characteristics related to nasal obstruction.
| Normal nasal findings (n = 44) | Positive anterior rhinoscopy findings (n = 32) | Positive nasopharyngoscopy findings (n = 34) | Any positive nasal findings (n = 46) | ||||
|---|---|---|---|---|---|---|---|
| Characteristic | p | p | p | ||||
| History of nasal surgery (%) | 20.5% | 31.3% | 0.2985 | 23.5% | 0.7872 | 28.3% | 0.6262 |
| Nasal obstruction diagnosis (%) | 11.4% | 40.6% | 0.0054 | 32.4% | 0.0455 | 37.0% | 0.0065 |
| Subjective nasal obstruction (%) | 20.5% | 46.9% | 0.0101 | 35.3% | 0.1986 | 34.8% | 0.1607 |
| Medical management (%) | 13.6% | 25% | 0.2411 | 17.6% | 0.7545 | 21.7% | 0.4111 |
Note: All characteristics are based on the patient's initial presentation to clinic. Medical management in this case happened to all be intranasal corticosteroid therapies. The nasal obstruction diagnosis category consists of rhinitis and sinusitis. Past nasal surgeries include function endoscopic sinus surgery (FESS), septoplasty, turbinoplasty, rhinoplasty, cancer removal, and trauma repair. p values are compared to the normal nasal finding group using a Fisher exact test. Bolded numbers signify p < 0.05.
The magnitude of changes in AHI, ESS, and FOSQ‐10 did not differ between patients with and without subjective nasal symptoms (p > 0.05). Similarly, no difference was found between symptomatic patients and those with objective nasal pathology but no symptoms (p > 0.05).
4. Discussion
In a population of patients who underwent hypoglossal nerve stimulator implantation with or without comorbid sinonasal pathology at a tertiary care center, this study reveals several notable findings. The defined cohorts were similar at baseline for age, BMI, preoperative AHI, ESS, and FOSQ‐10 results. Overall, objective measures of treatment efficacy (AHI improvement, Sher15 and 20 criteria satisfaction) were demonstrated in all groups following HNS. The magnitude of AHI improvement and Sher20 satisfaction rate in the current cohorts is slightly lower but mirrors similar pooled outcomes of a recent meta‐analysis that observed an approximately 20‐point decrease in AHI and 80% satisfaction of the Sher20 criteria within the 12‐month postoperative period [18]. Notably, there was a mix of titration studies and single amplitude studies, and titration studies can significantly overestimate the HNS efficacy [19]. However, our data demonstrated significant improvements (p < 0.001) across all cohorts, suggesting that observed improvements in AHI are robust and clinically meaningful, regardless of whether they were derived from titration PSG or single amplitude studies. Nonetheless, future studies could consider stratifying outcomes by study type to further explore potential differences in efficacy measurements.
Although FOSQ‐10 score did not significantly improve in the positive anterior rhinoscopy group, all other within‐group pre‐intervention and post‐intervention comparisons were significant, highlighting HNS's benefits. Similarly, the magnitude of FOSQ‐10 improvement was lower in the positive anterior rhinoscopy group compared to the normal nasal exam group; however, positive nasopharyngoscopy findings and any positive nasal findings (p = 0.061) did not predict a significantly lower improvement. Smaller QoL improvements observed in anterior rhinoscopy findings might reflect the greater impact of anterior nasal pathology, as this portion of the nasal cavity has the highest resistance to airflow [20]. Chronic mouth breathing from obstruction may worsen QoL in these patients more so than an obstruction in the posterior cavity, which nasopharyngoscopy may better capture. This is also evident when looking at the prevalence of subjective nasal obstruction symptoms in our cohorts, where patients with a positive anterior rhinoscopy had higher rates of subjective nasal obstruction. Interestingly, subjective nasal symptoms did not impact the magnitude of improvement of AHI, ESS, and FOSQ‐10, nor did symptomatic patients differ from those with objective nasal findings but no symptoms. This may suggest that HNS efficacy is independent of self‐reported nasal obstruction, reinforcing that subjective symptoms alone should not guide patient selection. Although limited by sample size, this could suggest that objective nasal findings better predict improvements in QoL following HNS than subjective nasal symptoms. Larger studies are needed to confirm this.
It is important to note that there were some overlaps between these groups; however, it is possible the patients exclusively in the positive nasopharyngoscopy group did not have severe enough pathology to interfere with natural airflow mechanics, thereby not impeding the improvement in FOSQ‐10 scores as severely. This could be explained by the lower sensitivity of anterior rhinoscopy narrowing positive findings down to clinically significant pathology. This observation is supported by previous literature describing the significantly negative correlation between Nasal Obstruction Symptom Evaluation (NOSE) scores and FOSQ‐10 scores in patients with nasal airway obstruction [21].
The FOSQ‐10 questionnaire encompasses five domains: general productivity, activity level, vigilance, social outcomes, and intimate and sexual relationships [22]. Interestingly, our sub‐analysis of individual question scores highlighted significantly lower improvements in Question 2 (general productivity), Question 6 (activity level), and Question 8 (activity level) for those that had positive anterior rhinoscopy findings; scores for questions 6 and 8 were also significantly lower in any positive nasal finding group. These findings highlight potential QoL domains that are not adequately addressed by HNS.
An interesting finding in this study is that ESS scores did not show significant differences within and across groups, while FOSQ‐10 did in some cases. One possible explanation for this is that ESS, which is scored out of 24, may be less sensitive to subtle changes compared to the FOSQ‐10, which is scored out of 40. The larger value range of FOSQ‐10 allows for more granular detection of smaller, but meaningful changes in QoL, making it a more sensitive tool for assessing nuanced improvements in functional outcomes. Additionally, ESS is focused on daytime sleepiness and alertness [23], while FOSQ‐10 captures multiple domains, which may be more affected by comorbid nasal pathology. It may be that comorbid nasal pathology in HNS does not have a large enough impact on daytime sleepiness to produce a significant change in ESS, but it interferes with patients' general productivity and activity level, which are better captured by FOSQ‐10. This potential discrepancy highlights that the implementation of multiple questionnaires to get a comprehensive understanding of patients' QoL is needed to fully evaluate the impact of HNS on patient well‐being, especially in the presence of comorbid sinonasal pathology.
This study has several limitations. First, it was retrospective in design, and all patients were treated at a single institution by a single surgeon, potentially limiting generalizability. While having a second otolaryngologist independently assess nasal exam findings would strengthen the study's validity, this was not feasible due to the retrospective nature of the study. Nasal findings were determined clinically, with no objective measurements (e.g., CT analysis and nasal partitioning ratio). While this reflects real‐world practice, further studies utilizing objective scales would increase reliability. Additionally, the relatively small sample size of each subgroup may limit the statistical power to detect smaller differences between groups. Future prospective studies with larger sample sizes should aim to further explore the relationship between nasal pathology and HNS outcomes, particularly in the realm of patient‐reported quality‐of‐life measures.
An additional limitation is the absence of a validated nasal obstruction questionnaire, such as the NOSE score, to quantify patient‐reported symptoms of nasal obstruction. This limitation arises from the retrospective study design, as NOSE questionnaires were not routinely administered at the time. Similarly, objective measures of nasal airflow, such as rhinomanometry or acoustic rhinometry, were not collected, preventing correlation between objective nasal findings and functional nasal airflow. However, existing literature has demonstrated a poor correlation between objective measures of nasal airflow and subjective nasal obstruction symptoms, which may limit the utility of such metrics in fully capturing patient experiences [24, 25]. Future prospective studies incorporating these measures could provide more robust insights into the relationship between nasal pathology and clinical outcomes.
Another limitation of this study was the overlapping patient groups. This overlap could introduce confounding factors when interpreting the differences between groups and dilute the ability to detect subtle differences between nasal pathology cohorts. As a result, the true impact of specific nasal pathologies on HNS efficacy and its effect on QoL may be masked by heterogeneity within each group. Further studies should consider more precise, mutually exclusive groupings or using multivariable analyses to control overlapping characteristics to better isolate the effects of different nasal pathologies on HNS outcomes.
5. Conclusion
This study demonstrates that HNS significantly improves AHI and ESS in patients with nasal pathology. However, patients with nasal abnormalities shown on anterior rhinoscopy showed less improvement in quality‐of‐life measures in FOSQ‐10 domains related to general productivity and activity levels. Despite this, nasal pathology does not affect the overall success of HNS in meeting Sher15 and Sher20 criteria. These findings suggest that while HNS effectively treats the physiological aspects of OSA, additional treatment for nasal pathology might be necessary to improve quality‐of‐life outcomes. Future studies should address the limitations of this study, such as its retrospective design and overlapping patient groups, and explore the benefits of managing nasal pathology alongside HNS to maximize patient outcomes and satisfaction.
Conflicts of Interest
Ryan Nord: Paid consultant for Inspire Medical Systems, the manufacturer of the device studied in this research. The other authors declare no conflicts of interest.
Adibi I., Nayak A., Saeedi A., Yu K., Bentan M., and Nord R. S., “Impact of Nasal Pathology on Efficacy of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea,” The Laryngoscope 135, no. 9 (2025): 3433–3440, 10.1002/lary.32172.
Funding: The authors received no specific funding for this work.
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