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Obstructive Sleep ApneaNICEPAPNCT05067088

Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

An observational study of Obstructive Sleep Apnea, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
CPAP (all patients receive CPAP as part of routine clinical care)
How many people
262 participants
Where
1 siteUnited States
Study dates
1 Jan 2022to 1 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale New Haven Hospital Sleep Center

    North Haven, Connecticut, 06473

Other trials in United States

About this study

Official title: Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness: NICEPAP Study Prospective Cohort

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.

Read the detailed description

Most patients with OSA who are prescribed the gold-standard therapy, CPAP, are ineffectively treated. This is due to 1) poor CPAP adherence, 2) high residual apnea in 20% of users (low efficacy) and 3) inconsistent symptom improvement. To improve CPAP effectiveness, we propose to address novel physiologic targets that cause OSA in each individual: arousability (arousal threshold), ventilatory control sensitivity (loop gain) and pharyngeal muscle compensation.

Our overall objective is to determine the contribution of these traits to CPAP effectiveness independently of established biological, psychological and social predictors. This study leverages state-of-the art sleep study analysis tools and validated measures of the determinants of CPAP effectiveness to create a pragmatic, prospective cohort (n=267) of OSA patients. This unique dataset will help determine whether physiologic causes of OSA influence CPAP adherence, efficacy, sleep quality, symptoms, function and quality of life. The results will inform design and conduct of a randomized clinical trial designed to modify physiologic traits such as easy arousability to improve CPAP effectiveness and other patient-centered outcomes in OSA patients.

Being tested
CPAP (all patients receive CPAP as part of routine clinical care)
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
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

    Continuous positive airway pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CPAP adherence

    average daily CPAP use (hours/night)

    Measured: 6 months

  2. CPAP efficacy

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

    Measured: 6 months

  3. 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.

    Measured: 6 months

Secondary outcomes (11)

  1. CPAP adherence (dichotomous)

    dichotomized measure of >4 hours/night for >70% of nights

    Measured: 3 months

  2. CPAP adherence

    average daily CPAP use (hours/night)

    Measured: 1 month

  3. CPAP adherence

    average daily CPAP use (hours/night)

    Measured: 12 months

  4. CPAP efficacy (dichotomous)

    residual AHI >=10/hour

    Measured: 6 months

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

    PROMIS scores, Range 0 - 40, higher scores reflect worse quality

    Measured: 6 months

  6. Sleep related impairment: Patient-Reported Outcomes Measurement Information System (PROMIS) scores

    PROMIS - impairment scores, range 0 - 40, higher scores reflect greater impairment

    Measured: 6 months

  7. Insomnia: Insomnia Severity Index (ISI)

    ISI scores, Range 0 - 28; higher scores reflect higher insomnia burden/severity

    Measured: 6 months

  8. Epworth sleepiness scale

    Epworth sleepiness scale scores, Range 0 - 24; higher scores signify greater sleepiness

    Measured: 6 months

  9. Anxiety: Hospital Anxiety and Depression Scale - Anxiety subscale scores

    Hospital Anxiety and Depression Scale - Anxiety subscale scores range 0 - 21; higher scores signify greater anxiety symptoms

    Measured: 6 months

  10. Depression: Hospital Anxiety and Depression Scale - Depression subscale scores

    Hospital Anxiety and Depression Scale - Depression subscale scores, Range 0 - 21; higher scores signify greater depression symptoms

    Measured: 6 months

  11. Attention

    median reaction time and mean slowest 10% reaction time from a 5-min smartphone-based psychomotor vigilance test.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start1 Jan 2022
  3. Primary completion1 May 2026
  4. Study completion1 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067088
Sponsor's protocol ID
2000024615
Other IDs
1K23HL159259-01
Acronym
NICEPAP
Status last verified
Jul 2026
First submitted
22 Sep 2021
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29734986

  • 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.

    PubMed 32083949

  • 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.

    PubMed 34156917

  • 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.

    PubMed 38995327

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CPAP adherence (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067088, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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