Understanding how physiological traits affect CPAP effectiveness in sleep apnea patients
Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness: NICEPAP Study Prospective Cohort
This study looks at how individual body traits affect how well CPAP treatment works for people with sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 267 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (North Haven, Connecticut) |
| Trial ID | NCT05067088 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of individual physiological traits on the effectiveness of continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). By examining factors such as arousability and ventilatory control sensitivity, the study seeks to identify how these traits influence CPAP adherence and efficacy. A cohort of 267 newly diagnosed OSA patients will be monitored to gather data on their CPAP use, sleep quality, and overall health outcomes. The findings will help inform future personalized treatment approaches for OSA.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been newly diagnosed with obstructive sleep apnea and are naïve to CPAP treatment.
Not a fit: Patients with central sleep apnea or those requiring supplemental oxygen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatments for patients with obstructive sleep apnea, improving their quality of life.
How similar studies have performed: While the approach of targeting physiological traits in OSA treatment is innovative, similar studies have shown promise in improving CPAP adherence and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of \>18 years 2. Newly diagnosed OSA naïve to CPAP 3. Apnea hypopnea index (AHI) ≥5/hr on in-laboratory polysomnography or home sleep test acquired and scored using standard criteria(59) 4. Referred for CPAP adherence management at Yale New Haven Hospital Sleep Center Exclusion Criteria: 1. Need for supplemental oxygen 2. Central apnea index comprising \>50% of the AHI 3. Treatment recommendation with another modality (e.g., Bilevel PAP, Adaptive Servo-Ventilation, Automatic Volume Pressure Assured Pressure Support) 4. A referral for a sleep disorder other than OSA (i.e., narcolepsy, sleep related movement disorder, circadian rhythm sleep-wake disorder) 5. Prior CPAP or Auto-CPAP use over the past 3 years 6. Unstable medical or mental health condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end stage renal disease, psychosis) 7. Inability to participate in the informed consent process (e.g., cognitive impairment) 8. Pregnancy 9. 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 this trial is running
North Haven, Connecticut
- Yale New Haven Hospital Sleep Center — North Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Andrey Zinchuk, MD, MHS — Yale University
- Study coordinator: Andrey Zinchuk, MD, MHS
- Email: andrey.zinchuk@yale.edu
- Phone: 475-655-6199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.