Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

NCT05067088 | Active Not Recruiting

• 2 other identifiers: 20000246151K23HL159259-01
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

Millions of Americans suffer from high blood pressure, diabetes, strokes and motor vehicle accidents due to ineffective treatment of obstructive sleep apnea (OSA). Our preliminary data suggest that physiological causes of OSA such as easy arousability (low arousal threshold) or unstable breathing control (high loop gain) may influence effectiveness of OSA's most common treatment, continuous positive airway pressure (CPAP). The NICE-PAP study will examine how the physiologic traits that cause OSA in each individual impact CPAP effectiveness and can lead to personalized OSA treatments that improve patient lives.

Conditions

Obstructive Sleep Apnea

Keywords

Continuous positive airway pressure (CPAP); Physiologic sleep apnea traits (endotypes); CPAP adherence; CPAP efficacy; Patient-centered sleep apnea outcomes; Precision medicine; Arousal threshold; Loop gain; Pharyngeal collapsibility; Pharyngeal muscle compensation

Outcome Measures

Primary Outcomes (3)

• CPAP adherence

  average daily CPAP use (hours/night)

  6 months

• CPAP efficacy

  average daily residual apnea hypopnea index on CPAP (events/hour)

  6 months

• OSA related quality of life measured by Functional Outcomes of Sleep Questionnaire (FOSQ) short form

  FOSQ short form average scores, Range 0 - 5, higher scores reflect worse quality of life and function.

  6 months

Secondary Outcomes (11)

• CPAP adherence (dichotomous)

  3 months

• CPAP adherence

  1 month

• CPAP adherence

  12 months

• CPAP efficacy (dichotomous)

  6 months

• Sleep quality: Patient-Reported Outcomes Measurement Information System (PROMIS) scores

  6 months

Interventions

CPAP (all patients receive CPAP as part of routine clinical care) OTHER

Continuous positive airway pressure

Also known as: Exposure: arousal threshold, Exposure: loop gain, Exposure: pharyngeal collapsibility, Exposure: pharyngeal muscle compensation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be drawn from the clinical population of patients referred for evaluation to the Yale New Haven Hospital Sleep Center. Currently, 38% of patients at YNHH with diagnosis of OSA are women, 65% are White, 12% Black, 10% Hispanic, 1% Asian, 1% Pacific Islander and remainder selecting other or unknown classification. We expect a similar proportion of enrolled subjects. Inclusion of vulnerable population subjects such prisoners or institutionalized individuals will be rare as these patients are infrequently evaluated sleep medicine clinics, however, they will not be excluded. Subjects who are undocumented immigrants to the U.S. will not be excluded and will undergo an informed consent process individualized in each encounter. Inclusion/exclusion criteria are noted above.

You may qualify if:

• Age of \>18 years
• Newly diagnosed OSA naïve to CPAP
• Apnea hypopnea index (AHI) ≥5/hr on in-laboratory polysomnography or home sleep test acquired and scored using standard criteria(59)
• Referred for CPAP adherence management at Yale New Haven Hospital Sleep Center

You may not qualify if:

• Need for supplemental oxygen
• Central apnea index comprising \>50% of the AHI
• Treatment recommendation with another modality (e.g., Bilevel PAP, Adaptive Servo-Ventilation, Automatic Volume Pressure Assured Pressure Support)
• A referral for a sleep disorder other than OSA (i.e., narcolepsy, sleep related movement disorder, circadian rhythm sleep-wake disorder)
• Prior CPAP or Auto-CPAP use over the past 3 years
• Unstable medical or mental health condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end stage renal disease, psychosis)
• Inability to participate in the informed consent process (e.g., cognitive impairment)
• Pregnancy
• Non-English language use as only means of communication (because the research budget does not provide adequate resources to ensure that the needs of non-English speaking patients can be adequately addressed)

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Yale New Haven Hospital Sleep Center

North Haven, Connecticut, 06473, United States

Location

Related Publications (4)

• Zinchuk A, Edwards BA, Jeon S, Koo BB, Concato J, Sands S, Wellman A, Yaggi HK. Prevalence, Associated Clinical Features, and Impact on Continuous Positive Airway Pressure Use of a Low Respiratory Arousal Threshold Among Male United States Veterans With Obstructive Sleep Apnea. J Clin Sleep Med. 2018 May 15;14(5):809-817. doi: 10.5664/jcsm.7112.

  PMID: 29734986 BACKGROUND

• Zinchuk AV, Redeker NS, Chu JH, Liang J, Stepnowsky C, Brandt CA, Bravata DM, Wellman A, Sands SA, Yaggi HK. Physiological Traits and Adherence to Obstructive Sleep Apnea Treatment in Patients with Stroke. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1568-1572. doi: 10.1164/rccm.201911-2203LE. No abstract available.

  PMID: 32083949 BACKGROUND

• Zinchuk AV, Chu JH, Liang J, Celik Y, Op de Beeck S, Redeker NS, Wellman A, Yaggi HK, Peker Y, Sands SA. Physiological Traits and Adherence to Sleep Apnea Therapy in Individuals with Coronary Artery Disease. Am J Respir Crit Care Med. 2021 Sep 15;204(6):703-712. doi: 10.1164/rccm.202101-0055OC.

  PMID: 34156917 BACKGROUND

• Anwar AI, Byrne S, Sharma A, Sands S, Wellman A, Redeker NS, Yaggi H, Zinchuk AV. Novel physiologic predictors of positive airway pressure effectiveness (NICEPAP) study: rationale, design and methods. Sleep Breath. 2024 Oct;28(5):2005-2015. doi: 10.1007/s11325-024-03099-w. Epub 2024 Jul 12.

  PMID: 38995327 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Andrey Zinchuk, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 5, 2021
• Study Start: January 1, 2022
• Primary Completion: January 30, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)