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Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine logoLink to Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine
. 2024 Jan 1;20(1):127–134. doi: 10.5664/jcsm.10836

Quality measures for the care of pediatric patients with obstructive sleep apnea: 2023 update after measure maintenance

Robin M Lloyd 1,, T’Auna Crawford 2, Ryan Donald 3, Diedra D Gray 2, William J Healy 4, Mithri R Junna 1, Daniel Lewin 5, Amee Revana 6, Sharon Schutte-Rodin 7
PMCID: PMC10758557  PMID: 37772707

Abstract

Obstructive sleep apnea (OSA) is the most common respiratory sleep disorder in the United States in preschool and school-aged children. In an effort to continue addressing gaps and variations in care in this patient population, the American Academy of Sleep Medicine (AASM) Quality Measures Task Force performed quality measure maintenance on the Quality Measures for the Care of Pediatric Patients with Obstructive Sleep Apnea (originally developed in 2015). The Quality Measures Task Force reviewed the current medical literature, including updated clinical practice guidelines and systematic literature reviews, existing pediatric OSA quality measures, and performance data highlighting remaining gaps or variations in care since implementation of the original quality measure set to inform any potential revisions to the quality measures. These revised quality measures have been implemented in the AASM Sleep Clinical Data Registry (Sleep CDR) to capture performance data and encourage continuous quality improvement, specifically in outcomes associated with diagnosing and managing OSA in the pediatric population.

Citation:

Lloyd RM, Crawford T, Donald R, et al. Quality measures for the care of pediatric patients with obstructive sleep apnea: 2023 update after measure maintenance. J Clin Sleep Med. 2024;20(1):127–134.

Keywords: pediatrics, obstructive sleep apnea, quality measures

INTRODUCTION

Several 2012 publications in the medical literature indicated that the prevalence of obstructive sleep apnea (OSA) among children was 1–5%.1,2 While the prevalence of this respiratory sleep disorder in children has increased slightly, there continue to be gaps and variations in care regarding screening and treatment and/or management of pediatric OSA.3

The original Obstructive Sleep Apnea Physician Performance Measurement Set (https://aasm.org/wp-content/uploads/2017/08/PCPI-OSA-Measures.pdf) was developed in 2008 by the American Academy of Sleep Medicine (AASM), in collaboration with the American Medical Association, the National Committee on Quality Assurance, and several other medical specialty societies. The 2008 quality measure set was approved by the Centers for Medicare & Medicaid Services for inclusion in the Physician Quality Reporting System (PQRS). The Quality Measures for the Care of Pediatric Patients with Obstructive Sleep Apnea were developed in 2015, as an extension to the original adult OSA measure set. Two of the pediatric OSA measures were included in the Merit-based Incentive Payment System (MIPS) program, as Qualified Clinical Data Registry (QCDR) measures in 2021: Pediatric OSA: Objective Assessment of Positive Airway Pressure Therapy Adherence and Pediatric OSA: Objective Assessment of OSA Signs and Symptoms in Children with Complex Medical Conditions. The MIPS program replaced PQRS as a part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). All of the revised pediatric OSA measures are also currently available for reporting via the AASM Sleep Clinical Data Registry (Sleep CDR), which was established as the first sleep-specific registry.

The AASM convened the Quality Measures Task Force to review the entire AASM quality measure portfolio and to ensure that all quality measures are consistent with current evidence, as defined by clinical practice guideline recommendations, systematic literature reviews, and other published studies within the medical literature. Updating the measure set also required a review of existing quality measures for the purposes of quality measure harmonization, which ensures that measures are not repetitive or competing. Lastly, the reviews include a search for performance data for measures implemented via clinical data registries and national quality-reporting programs, coupled with identifying variations in care for pediatric patients with OSA.

METHODS

Literature review

An updated comprehensive literature search was conducted to identify current publications that addressed pediatric OSA in terms of the quality measures within this quality measure set. The literature review included clinical practice guidelines, systematic literature reviews, and individual studies (ie, randomized controlled trials). Searches were limited to articles published between 2015 and 2019, specific to humans, in the English language, and meeting the age criteria within the PubMed database. Publication types such as news articles, letters, editorials, and case reports were excluded. A total of 192 abstracts and 51 full journal publications were retrieved for review.

Performance data

In addition to a review of the medical literature, the Task Force searched for performance data, which may demonstrate performance gaps and/or variations in care. No data were identified, as the AASM only recently developed an implementation vehicle for quality measures (Sleep CDR). The measures had not yet been implemented in any other clinical data registry and no MIPS data were available, as the Task Force searched for performance data prior to these measures being included in the program as QCDR measures.

Existing quality measures

As a part of the measure maintenance process, the Task Force also reviewed existing quality measures and determined that there were no existing pediatric OSA measures that required measure harmonization. The Centers for Medicare & Medicaid Services defines measure harmonization as standardizing quality measure specifications for related measures when they have the following4:

  • The same measure focus (ie, numerator criteria)

  • The same target population (ie, denominator criteria)

  • Elements that apply to many measures (eg, age designation for children)

Unintended consequences

There were no known unintended consequences identified as a result of reporting the pediatric OSA quality measures.

Review and approval

The measures were initially revised and approved for public comment by the AASM Board of Directors. The measures were then posted on the AASM website for a 30-day public comment period and were simultaneously shared with several medical specialty societies for an additional peer review, to ensure that all relevant stakeholders had an opportunity to provide feedback. The Task Force reviewed all stakeholder feedback and made additional revisions, where deemed appropriate. The final revised measures were approved for publication and implementation by the AASM Executive Committee. A driver diagram of the final measures is shown in Figure 1.

Figure 1. Revised pediatric OSA quality measures driver diagram.

Figure 1

OSA = obstructive sleep apnea, PSG = polysomnography.

REVISED QUALITY MEASURES

Process measure 1—Assessment of OSA signs, symptoms, and risk factors

2015 Measure description

Proportion of patients aged < 18 years with snoring that had documentation of an assessment of at least 1 obstructive sleep apnea (OSA) symptom or risk factor.

Revised measure description

Proportion of patients aged < 18 years with snoring that had documentation of an assessment of at least 1 additional sign or symptom or risk factor of OSA from the patient’s history or physical examination at baseline visit.

Exceptions and exception justifications

  • Medical reasons: None

  • Patient reasons: None

  • System reasons: None

Supporting evidence and rationale for revisions

Pediatric OSA continues to be a prevalent condition that may be characterized by atypical sleep patterns, behavioral challenges, learning difficulties, and/or cardiovascular complications, and may potentially have long-term implications for patients.57 However, many children continue to go undiagnosed, despite demonstrating common signs and/or symptoms of OSA, which highlights that there is a gap in care. Upon initial review of this quality measure, the Task Force discussed whether it would be appropriate to potentially modify and identify specific age groups included in the denominator language. The group discussed whether there are differences in how children and adolescents of differing ages may be screened for OSA. Ultimately, no changes were made to the age group, as there were no defining data in the medical literature that highlighted differences in how pediatric OSA should be identified in pediatric patients of different age groups. The group also discussed whether to continue including snoring in the denominator, as there are additional symptoms and risk factors of OSA. However, as snoring is very commonly associated with sleep apnea in the pediatric patient population, the current denominator language was maintained. Potential modifications to the numerator were also considered. The original numerator language did not include details regarding how the patient was assessed for OSA. In lieu of focusing on specific validated instruments, the measure will emphasize signs, symptoms, and risks captured during the history and physical examination. The medical literature, including AASM clinical practice guidelines,8,9 recommend a comprehensive sleep evaluation at an initial visit, prior to any diagnostic testing, and recommend that validated instruments, including clinical tools, questionnaires, and prediction algorithms, not be used in isolation to diagnose OSA. Additionally, when used, any validated instruments should be accompanied by a provider interpretation. Utilizing medical evidence and consensus, it was decided that the Process Measure #1 numerator should include signs, in addition to symptoms and risk factors. The signs, symptoms, and risk factors lists were then reviewed and updated.

The original decision not to include exceptions was reaffirmed, as there would not be an instance where a patient visiting for a primary complaint of snoring would not be assessed for other OSA signs, symptoms, or risk factors during a history and physical examination.

Process measure 2—Recommendation of an evidence-based action plan

2015 Measure description

Proportion of patients aged < 18 years with signs and symptoms of OSA that are offered watchful waiting/medical management, surgical management, referral for polysomnography (PSG) testing, or referral to a sleep specialist, otolaryngologist, or other specialist experienced in evaluation and management of sleep-disordered breathing in children within 12 months of the visit in which the signs and symptoms of OSA were first discussed.

Revised measure description

Proportion of patients aged < 18 years with snoring and at least 1 sign, symptom, or risk factor of OSA that are offered an evidence-based action plan within 12 months of the visit in which the signs and symptoms of OSA were first discussed.

  • Note: Patients with complex medical conditions may require evaluation and management sooner than 12 months from the visit in which the signs and symptoms of OSA were first discussed.

  • Definition: For the purposes of this measure, complex medical conditions may include, but are not limited to, Down syndrome, morbid obesity, poor weight gain, sickle cell disease, achondroplasia, Prader-Willi syndrome, craniofacial abnormalities, other genetic syndromes, neuromuscular disorders, storage diseases, cor pulmonale related to OSA.

  • Definition: For the purposes of this measure, an evidence-based action plan may include watchful waiting/medical management, surgical management, referral for PSG testing, or referral to a sleep specialist, otolaryngologist, dental, or other specialist experienced in evaluation and management of sleep-disordered breathing in children.

Exceptions and exception justifications

  • Medical reasons: None

  • Patient reasons: None

  • System reasons: None

Supporting evidence and rationale for revisions

Untreated pediatric OSA has been linked to behavioral issues, learning challenges, and neurocognitive impairments. In more severe cases, untreated patients can also experience impaired growth and cardiovascular complications.10 This measure was revised with the understanding that there continues to be variations in care for pediatric patients with OSA, based on severity, pre-existing conditions, and many other factors such as patient and caregiver preference. The denominator language for this measure was modified to include patients with added risk factors and to define complex conditions, in addition to signs and symptoms. This also aligns this measure with the revisions to Process Measure #1, which now includes risk factors in the evaluation during the baseline visit. When considering potential revisions to the numerator language, the Task Force noted that the medical literature continues to support the list of evidence-based actions. However, removing evidence-based action plans from the numerator language, and instead including them in a definition, makes the measure language more clear, streamlined, and feasible for implementation. The definition includes a list of updated evidence-based actions, which is included with the numerator and also captured in the technical specifications. Dentists with expertise in treating OSA were included in the list of specialists that may be referred to for treatment of OSA. The Task Force initiated a discussion regarding a potential difference in the treatment for pediatric patients with pre-existing complex medical conditions who are now displaying signs, symptoms, or risk factors of OSA. To ensure clarity with regard to complex medical conditions, a definition was added, which includes a list of complex medical conditions that may require earlier intervention. Additionally, a numerator notation was added that patients with pre-existing complex medical conditions may require evaluation and management sooner than 12 months. These conditions were previously included in the 2015 measure as measure exceptions but were moved to the numerator, given the revision from “initiation” to “recommendation” of an evidence-based action plan. Certain interventions may not be appropriate for patients with complex medical conditions, but recommendations for watchful waiting, treatment(s), or referral(s) should be documented for all patients. The patient and system exceptions were also removed from the measure, as the original measure included a patient or insurance refusal of initiation of treatment. However, while the patient or insurance may refuse therapy or recommendations, the provider is required to offer and document an evidence-based plan and therapy options.

Process measure 3—Objective assessment of OSA signs and symptoms in children with complex medical conditions

2015 Measure description

Proportion of patients aged < 18 years with complex medical conditions known to be at high risk for OSA and with signs and symptoms of OSA who underwent a PSG or were referred to a sleep specialist, otolaryngologist, or other specialist experienced in the evaluation and management of OSA in children.

Revised measure description

Proportion of patients aged < 18 years with complex medical conditions known to be at high risk for OSA and with signs or symptoms of OSA that received an order for an objective assessment, which would include both a PSG and evaluation by a sleep specialist, otolaryngologist, or other specialist experienced in evaluation and management of OSA in children.

  • Definition: For the purposes of this measure, complex medical conditions may include but are not limited to Down syndrome, morbid obesity, poor weight gain, sickle cell disease, achondroplasia, Prader-Willi syndrome, craniofacial abnormalities, other genetic syndromes, neuromuscular disorders, storage diseases, cor pulmonale related to OSA.

Exceptions and exception justifications

  • Medical reasons: Patients with unstable cardiopulmonary, neurological, psychiatric, or other medical conditions that may impact the validity of the sleep study, or unstable mental condition; patients with allergy to sensors

  • Patient reasons: Patient cannot tolerate testing (testing is terminated), patient or caregiver declines assessment at the time of the evaluation

  • System reasons: Patient’s insurance (payer) does not provide coverage

Supporting evidence and rationale for revisions

Many children with complex medical conditions have been found to be at high risk for OSA. A review of the medical literature confirmed that children with comorbidities should continue to be assessed for OSA, given the cognitive, behavioral, neurological, and physical signs and symptoms experienced by this patient population.11,12 To clarify which pediatric patients would be considered high-risk populations, a definition of complex medical conditions was included in the denominator. The lists of signs, symptoms, and risk factors were also modified in the denominator, to align with common signs and symptoms identified in clinical practice. Unstable neurologic, psychiatric, and other medical conditions were added to the cardiopulmonary conditions as medical exceptions. One of the smallest, yet most pertinent, changes to the denominator was to change the language to signs “or” symptoms of OSA. The previous version of the measure required both signs and symptoms, which the Task Force thought should be modified to ensure that patients with OSA and complex medical conditions were not excluded from the measure for not showing both signs and symptoms. Each individual sign and symptom is significant and indicates a need for further evaluation and diagnostic testing.

When evaluating the numerator language, the Task Force considered the potential unintended consequences of the original version of the measure. The initial numerator language captured patients who underwent a polysomnogram, but this meant that providers may not meet the measure if they ordered PSG for the patient and the test was ultimately not performed, for any reason. Therefore, the numerator language was revised to capture the provider ordering the PSG instead. Additionally, the Task Force discussed the idea of having PSG performed or being referred to an appropriate specialist. Ultimately, both of these actions are required, as both should be performed in order to ensure high-quality care for the patient.

The measure exception language was also further refined to clarify the intent. The medical exception language was revised to be more specific with the types of conditions that may qualify and to highlight that these conditions are included as medical exceptions because they may impact the validity of the PSG study. The patient exception required a more in-depth discussion, as the Task Force discussed how impactful the caregiver preference may be to ordering PSG and on the patient evaluation by an appropriate specialist. Caregiver preference for watchful waiting was removed, because appropriate care should still be offered and documented (ie, order for the PSG AND referral to a specialist) as part of the discussion of expert recommendations. However, caregivers can decline any such recommendation, so the patient reason exception was, therefore, modified to include caregiver declining the assessment or the testing not being tolerated.

Process measure 4—Reassessment of OSA signs and symptoms

2015 Measure description

Proportion of patients aged < 18 years diagnosed with OSA whose abnormal signs and symptoms attributable to OSA were reassessed within 12 months of initiating a management plan.

Revised measure description

Proportion of patients aged < 18 years diagnosed with OSA whose signs and symptoms attributable to OSA were reassessed within 6 months and at least annually after initiating a management plan.

  • Definition: For the purposes of this measure, a management plan may include watchful waiting/medical management, surgical management, referral for PSG testing, or referral to a sleep specialist, otolaryngologist, dental, or other specialist experienced in evaluation and management of sleep-disordered breathing in children.

Exceptions and exception justifications

  • Medical reasons: None

  • Patient reasons: Patient does not return for follow-up; patient or caregiver refuses treatment; patient cannot afford treatment

  • System reasons: Patient’s insurance (payer) does not cover reassessment

Supporting evidence and rationale for revisions

When monitoring patient outcomes, it is important to assess the effectiveness of OSA treatment and management interventions, while working to improve the signs and symptoms that patients experienced at their baseline visit. Ideally, the patient and/or patient’s caregiver will report improvement in the signs and symptoms initially displayed by the patient. Although this is a process measure, this additional assessment is an important intermediate step in order to collect data-assessing improvements in patient outcomes. During the review of the measure intent and language, the initiation of a management plan was added to the denominator. The patient population should only include those who have had a management plan implemented, so the follow-up assessment can demonstrate the effectiveness of that plan. The numerator modifications primarily speak to the timing of reassessing signs and symptoms for newly diagnosed patients. Based on clinical experience, the Task Force reached consensus that the initial reassessment of signs and symptoms should take place within the first 6 months after the baseline visit to allow for modifications to management plans, as needed. The patient should then be seen on an annual basis, at a minimum, after the initial follow-up visit, for additional follow-up assessments, as patients may require modifications to their OSA treatment plans. The only additional change to the numerator language is the removal of the word “abnormal,” as it is redundant when referring to the described OSA signs and symptoms. There was only 1 significant modification to the medical exceptions for this quality measure. The initial measure included a medical exception for patients who had been diagnosed with terminal or advanced disease and a limited life span. However, since terminal patients may be captured in the denominator of this measure and OSA treatment may provide comfort, this medical exception was removed. This population should also have follow-up assessment within 6 months after initiating a treatment plan to assess treatment benefits and comfort.

Process measure 5—Objective assessment of positive airway pressure therapy adherence

2015 Measure description

Proportion of patients aged < 18 years diagnosed with OSA who were prescribed positive airway pressure (PAP) therapy and had documentation of objectively measured adherence to PAP therapy within 3 months of starting therapy.

Revised measure description

Proportion of patients aged < 18 years diagnosed with OSA that were prescribed positive airway pressure therapy and had documentation of objectively measured adherence to positive airway pressure therapy within 3 months of starting therapy and at least annually.

Exceptions and exception justifications

  • Medical reasons: None

  • Patient reasons: Patient or caregiver declines to use PAP therapy; patient does not return for follow-up; patient or caregiver does not provide an electronic data card or wireless transmitter with the adherence data

  • System reasons: Patient did not receive equipment as prescribed; objective adherence mechanism is not available; modem or memory device is nonfunctional and cannot transmit objective adherence data; ongoing PAP denied by insurance; PAP device recalled and not replaced by manufacturer

Supporting evidence and rationale for revisions

Long-term PAP adherence has been proven to reduce daytime sleepiness, blood pressure, cardiovascular disease risk and status, and improve behavior, cognitive performance, glucose control and overall quality of life for patients with OSA.1316 While several factors have been identified as potential predictors of adherence, the Task Force agreed that the initial follow-up after only 3 months of PAP therapy was insufficient and that additional follow-up of chronic OSA is warranted. Since the 2015 measure language seemed primarily consistent with the medical literature, there were no revisions to the denominator language. However, the numerator language was revised to ensure that adherence continues to be monitored at least annually, after the initial 3-month follow up period. Ongoing monitoring at annual visits, minimally, will enable the provider to evaluate whether the patient is tolerating the PAP therapy, as well as to determine whether PAP therapy requires adjustments to effectively treat OSA. OSA is a chronic condition requiring long-term management. Additionally, the medical literature indicates that the primary challenge with PAP therapy is adherence to this long-term treatment, which supports the addition of the annual visit, and directly addresses a gap in care for this patient population.

There were no changes to the medical or patient reason exceptions. However, several modifications were made to the system reason exceptions. It is well-documented that cost-related issues are significant barriers to PAP compliance, and it is extremely important to capture these data to highlight socioeconomic barriers to appropriate care.17 The Task Force also included system reason exceptions acknowledging and relating to device technical issues and manufacturer recalls, which contribute to workflow disruptions in care and increase gaps in medical device inventory, modem availability, and objective data surveillance of patients with sleep apnea.1820

Outcome measure—Improvement in signs or symptoms of OSA

2015 Measure description

Proportion of patients aged < 18 years diagnosed with OSA who showed a reduction in OSA signs or symptoms within 12 months after initiation of a management plan.

Revised measure description

Proportion of patients aged < 18 years diagnosed with OSA that showed an improvement in OSA signs or symptoms within 12 months after initiation of a management plan.

Exceptions and exception justifications

  • Medical reasons: None

  • Patient reasons: Patient does not return for follow-up; patient or caregiver declines treatment; patient cannot afford treatment

  • System reasons: Patient’s insurance (payer) does not provide coverage

Supporting evidence and rationale for revisions

Assessing signs and symptoms of OSA 1 year after initiating a management plan is helpful in identifying treatment effectiveness, identifying any necessary treatment modifications, or recognizing that the current management plan is effective and is improving quality of life for the patient. The most helpful manner of assessing any improvement in signs and/or symptoms would be to repeat the initial method(s) of assessment performed at the patient’s baseline visit. The Task Force spent a significant amount of time discussing the only change in the numerator language, which modified the measure action from “reduction of signs or symptoms” to “improvement in signs or symptoms,” as while the total number of OSA signs and symptoms a patient is experiencing may not change within the quality measure reporting period, patients may report improvements after an appropriate evaluation and diagnostic testing, followed by implementation of a management plan. When validated instruments are used to assess improved outcomes, a provider interpretation must accompany the scores. No other changes were made to the primary measure components.

The measure has also been designated for implementation as a quality-improvement measure, as the group had concerns that providers might be held accountable and have reimbursement linked to a potential lack of improvement in signs or symptoms for the patient. There are any number of factors that may impact whether the patient improves, including comorbidities, nonadherence, socioeconomic, and other factors. This measure will be implemented into the Sleep CDR but is not recommended for accountability in any national quality-reporting program, private payer quality metrics, or any other quality-improvement initiative associated with reimbursement.

The exception language has been modified to update the patient reason exceptions to capture patients who do not return for follow-up, decline treatment, or cannot afford treatment. A system reason was also added to capture a payer not providing coverage. Again, collection of these data will allow for future analyses of the potential impact of cost on sleep disorder treatment.

IMPLEMENTATION STRATEGIES

This revised quality measure set has been implemented into the Sleep CDR. The clinical data registry was established by the AASM in May of 2021 and contains the entire AASM sleep-specific quality measure portfolio. The registry was approved by the Centers for Medicare & Medicaid Services as a Qualified Clinical Data Registry (QCDR), for reporting quality measures as a part of the Quality Payment Program, a national quality-reporting initiative that includes MIPS. The registry is a measure implementation vehicle that can also be used for quality measure validation, and to collect data for scientific acceptability, benchmarking, quality improvement, and research. Sleep CDR is currently available to all AASM-accredited facilities and affiliated clinicians.

FUTURE DIRECTIONS

Digitalized data collection has enhanced the ability to collect process measure data and to analyze outcomes-related data with the goal of improving patient care. These data allow practice benchmarks to be collected and analyzed for quality improvements and practice interventions to improve patient outcomes. Further, the aggregation of local benchmarks allows practices to recognize national quality measure benchmarks, to acknowledge and understand areas for practice quality-improvement interventions, and to continue quality measure reassessments over time. Collection of patient-reported outcomes has increased with e-questionnaires delivered through electronic health record patient portals, and some practices have integrated testing and therapy monitoring data into the electronic health record. Collection and analysis of quality measure “big data” will become increasingly useful in the future to direct improved personalized care models and standards of practice. With this current set of updated measures, the Task Force attempted to recognize a standard approach that includes practices transitioning from paper to electronic quality measure documentation. The future includes understanding that quality measures will continue to require updates as rapid changes in technologies, data accuracy, and reporting are occurring for diagnostic testing, evidence-based therapeutic options, and remote data-monitoring capabilities. Since publication of the original pediatric OSA quality measures,21 major obstacles, such as the COVID-19 pandemic and related insurance changes, PAP recalls, device and modem shortages, and others, have disrupted workflow and OSA care. The Task Force attempted to adapt measures to account for new and future technologies, as well as unforeseen workflow and practice disruptors.

DISCLOSURE STATEMENT

Dr. Revana is currently the principal investigator of a phase 2 clinical trial at Harmony Biosciences, LCC, and a consultant at Trend, LLC. Dr. Donald holds stock in the following entities: Becton, Dickinson and Company, Medtronic, and Zimmer Biomet Holdings, Inc. Dr. Junna is Secretary of the Minnesota Sleep Society Board of Directors. Ms. Crawford and Ms. Gray are employed by the AASM. The other authors report no conflicts of interest.

ACKNOWLEDGMENTS

The AASM thanks the American Academy of Neurology for their review of these measures and providing feedback and suggestions for additional revisions to capture the true intent of the measures. The AASM did not seek or receive endorsement of these measures from this organization.

ABBREVIATIONS

AASM

American Academy of Sleep Medicine

OSA

obstructive sleep apnea

PAP

positive airway pressure

PSG

polysomnography

Sleep CDR

AASM Sleep Clinical Data Registry

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