Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT05067088
• Lead Sponsor: Yale University

Brief 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 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-05
• Study Start: 2022-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-09-30
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 267

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CPAP adherence	6 months	average daily CPAP use (hours/night)
OSA related quality of life measured by Functional Outcomes of Sleep Questionnaire (FOSQ) short form	6 months	FOSQ short form average scores, Range 0 - 5, higher scores reflect worse quality of life and function.
CPAP efficacy	6 months	average daily residual apnea hypopnea index on CPAP (events/hour)

Secondary Outcome Measures

Name	Time	Method
CPAP adherence (dichotomous)	3 months	dichotomized measure of \>4 hours/night for \>70% of nights
CPAP adherence	12 months	average daily CPAP use (hours/night)
Sleep quality: Patient-Reported Outcomes Measurement Information System (PROMIS) scores	6 months	PROMIS scores, Range 0 - 40, higher scores reflect worse quality
Insomnia: Insomnia Severity Index (ISI)	6 months	ISI scores, Range 0 - 28; higher scores reflect higher insomnia burden/severity
CPAP efficacy (dichotomous)	6 months	residual AHI \>=10/hour
Epworth sleepiness scale	6 months	Epworth sleepiness scale scores, Range 0 - 24; higher scores signify greater sleepiness
Attention	6 months	median reaction time and mean slowest 10% reaction time from a 5-min smartphone-based psychomotor vigilance test.
Sleep related impairment: Patient-Reported Outcomes Measurement Information System (PROMIS) scores	6 months	PROMIS - impairment scores, range 0 - 40, higher scores reflect greater impairment
Anxiety: Hospital Anxiety and Depression Scale - Anxiety subscale scores	6 months	Hospital Anxiety and Depression Scale - Anxiety subscale scores range 0 - 21; higher scores signify greater anxiety symptoms
Depression: Hospital Anxiety and Depression Scale - Depression subscale scores	6 months	Hospital Anxiety and Depression Scale - Depression subscale scores, Range 0 - 21; higher scores signify greater depression symptoms

Trial Locations

Locations (1)

Yale New Haven Hospital Sleep Center; 🇺🇸 North Haven, Connecticut, United States