Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.
Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and comorbid insomnia.
Specific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation.
Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.
详细描述
OSA is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of OSA treatment. It is currently unknown if direct treatment of insomnia will enhance outcomes of OSA treatment. The investigators at the Rush Sleep Disorders Center have developed an approach that combines CBT for insomnia delivered by a psychologist with CPAP therapy managed by a physician. Building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating OSA using CPAP alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females age 18 and older.
- •Meets criteria for Obstructive Sleep Apnea
- •Meets criteria for an Insomnia Disorder
排除标准
- •Comorbid medical condition that requires immediate treatment of OSA
- •Severe cases of OSA that require immediate treatment
- •Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment
- •Comorbid sleep disorders that require treatment outside of the study protocol
- •Other sleep-related breathing disorder besides OSA
- •Excessive daytime sleepiness that requires immediate treatment or presents significant risk
- •CPAP use or formal CBT for insomnia within the past 6 months
研究组 & 干预措施
Model A
Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
干预措施: CBT-I (Behavioral)
Model A
Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II.
干预措施: CPAP (Procedure)
Model B
Model B consists of 4 weeks of monitoring using sleep diaries in Phase I. Phase II consists of concurrent initiation of CBT-I and CPAP for OSA.
干预措施: CBT-I (Behavioral)
Model B
Model B consists of 4 weeks of monitoring using sleep diaries in Phase I. Phase II consists of concurrent initiation of CBT-I and CPAP for OSA.
干预措施: CPAP (Procedure)
Model C
Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA.
干预措施: CPAP (Procedure)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 90 days after CPAP initiation
Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation.
CPAP adherence
时间窗: 90 days after CPAP initiation
CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights)
次要结局
- Polysomnography (PSG)(End of phase 1 (1 month after baseline assessment))
- Actigraphy(90 days after CPAP initiation)
- Insomnia Severity Index (ISI)(90 days after CPAP initiation)
- Functional Outcomes of Sleep Questionnaire (FOSQ)(90 days after CPAP initiation)
研究者
Jason Ong
Associate Professor
Northwestern University