Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05067088

Run by

Yale University

People needed

262

Starts

2022-01-01

Expected to finish

2026-05-01

Last updated by the study team

2026-08-03

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Yale New Haven Hospital Sleep Center — North Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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