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.
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.
Study Type
OBSERVATIONAL
Enrollment
267
Continuous positive airway pressure
Yale New Haven Hospital Sleep Center
North Haven, Connecticut, United States
CPAP adherence
average daily CPAP use (hours/night)
Time frame: 6 months
CPAP efficacy
average daily residual apnea hypopnea index on CPAP (events/hour)
Time frame: 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.
Time frame: 6 months
CPAP adherence (dichotomous)
dichotomized measure of \>4 hours/night for \>70% of nights
Time frame: 3 months
CPAP adherence
average daily CPAP use (hours/night)
Time frame: 1 month
CPAP adherence
average daily CPAP use (hours/night)
Time frame: 12 months
CPAP efficacy (dichotomous)
residual AHI \>=10/hour
Time frame: 6 months
Sleep quality: Patient-Reported Outcomes Measurement Information System (PROMIS) scores
PROMIS scores, Range 0 - 40, higher scores reflect worse quality
Time frame: 6 months
Sleep related impairment: Patient-Reported Outcomes Measurement Information System (PROMIS) scores
PROMIS - impairment scores, range 0 - 40, higher scores reflect greater impairment
Time frame: 6 months
Insomnia: Insomnia Severity Index (ISI)
ISI scores, Range 0 - 28; higher scores reflect higher insomnia burden/severity
Time frame: 6 months
Epworth sleepiness scale
Epworth sleepiness scale scores, Range 0 - 24; higher scores signify greater sleepiness
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
Attention
median reaction time and mean slowest 10% reaction time from a 5-min smartphone-based psychomotor vigilance test.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.