Improving Outcomes for Patients With SDB and Insufficient Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 2
- 主要终点
- Epworth Sleepiness Scale (ESS)
研究概览
简要总结
The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness.
In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.
详细描述
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB.
This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.
Both groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.
Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Current use of PAP or oral appliance therapy for SDB
- •Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)
- •A recent health event that may affect sleep (e.g. recent surgery or hospitalization)
- •Current alcohol or substance use disorder (<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis)
- •Pregnancy or within 6 months post-partum
- •Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS>18
- •Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and
- •Central sleep apnea (defined as central apnea/hypopnea index >5, and >50% of total AHI).
- •Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range.
结局指标
主要结局
Epworth Sleepiness Scale (ESS)
时间窗: 3-months after randomization
ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness.
次要结局
- Reactive hyperemia index(3-months after randomization)
- 24-hours Ambulatory Blood Pressure(3-months after randomization)
- Fatigue Severity Scale (FSS)(3-months after randomization)
- Psychomotor Vigilance Test (PVT)(3-months after randomization)
研究者
Safwan Badr
Professor of Medicine
Wayne State University