Yale New Haven Hospital Sleep Center
North Haven, Connecticut, 06473, United States
NCT Number: NCT05067088
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.
This study is active but is not currently recruiting participants.
19 year and older
All sexes
Observational
North Haven, Connecticut, 06473, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous positive airway pressure
Other names: Exposure: arousal threshold, Exposure: loop gain, Exposure: pharyngeal collapsibility, Exposure: pharyngeal muscle compensation
Time frame: 6 months
average daily CPAP use (hours/night)
Time frame: 6 months
average daily residual apnea hypopnea index on CPAP (events/hour)
Time frame: 6 months
FOSQ short form average scores, Range 0 - 5, higher scores reflect worse quality of life and function.
Time frame: 3 months
dichotomized measure of >4 hours/night for >70% of nights
Time frame: 1 month
average daily CPAP use (hours/night)
Time frame: 12 months
average daily CPAP use (hours/night)
Time frame: 6 months
residual AHI >=10/hour
Time frame: 6 months
PROMIS scores, Range 0 - 40, higher scores reflect worse quality
Time frame: 6 months
PROMIS - impairment scores, range 0 - 40, higher scores reflect greater impairment
Time frame: 6 months
ISI scores, Range 0 - 28; higher scores reflect higher insomnia burden/severity
Time frame: 6 months
Epworth sleepiness scale scores, Range 0 - 24; higher scores signify greater sleepiness
Time frame: 6 months
Hospital Anxiety and Depression Scale - Anxiety subscale scores range 0 - 21; higher scores signify greater anxiety symptoms
Time frame: 6 months
Hospital Anxiety and Depression Scale - Depression subscale scores, Range 0 - 21; higher scores signify greater depression symptoms
Time frame: 6 months
median reaction time and mean slowest 10% reaction time from a 5-min smartphone-based psychomotor vigilance test.
Yale University
Other
Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness: NICEPAP Study Prospective Cohort
Acronym: NICEPAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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