Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness: NICEPAP Study Prospective Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- OSA related quality of life measured by Functional Outcomes of Sleep Questionnaire (FOSQ) short form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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)
结局指标
主要结局
OSA related quality of life measured by Functional Outcomes of Sleep Questionnaire (FOSQ) short form
时间窗: 6 months
FOSQ short form average scores, Range 0 - 5, higher scores reflect worse quality of life and function.
CPAP adherence
时间窗: 6 months
average daily CPAP use (hours/night)
CPAP efficacy
时间窗: 6 months
average daily residual apnea hypopnea index on CPAP (events/hour)
次要结局
- CPAP adherence(1 month)
- CPAP adherence(12 months)
- Sleep quality: Patient-Reported Outcomes Measurement Information System (PROMIS) scores(6 months)
- Insomnia: Insomnia Severity Index (ISI)(6 months)
- CPAP adherence (dichotomous)(3 months)
- CPAP efficacy (dichotomous)(6 months)
- Epworth sleepiness scale(6 months)
- Attention(6 months)
- Sleep related impairment: Patient-Reported Outcomes Measurement Information System (PROMIS) scores(6 months)
- Anxiety: Hospital Anxiety and Depression Scale - Anxiety subscale scores(6 months)
- Depression: Hospital Anxiety and Depression Scale - Depression subscale scores(6 months)