Cognitive Behavioral Therapy for Insomnia to Improve Upper Airway Stimulation Adherence in Comorbid Insomnia and Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- UAS adherence
研究概览
简要总结
Obstructive sleep apnea, or OSA, affects over 1 billion adults worldwide. OSA is one of many sleep disorders. Individuals can suffer from more than one sleep disorder at a time. Insomnia (difficulty falling or staying asleep) is a separate sleep disorder that is very often seen in OSA patients. Depending on reports, insomnia can be present in 30%-60% of patients diagnosed with OSA. This research is being conducted to determine whether treating insomnia can help patients with OSA to have better outcomes when treating their OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •being seen and treated at the designated study locations for OSA with:
- •a diagnosis of insomnia (defined as ISI ≥10, or prescribed hypnotic medication (trazadone, zolpidem, eszopiclone, doxepin), or a diagnosis of insomnia [International Classification of Sleep Disorders 3 criteria]).
- •internet-capable device (e.g., smartphone, tablet, or computer)
- •able to download and use the COAST app for administration of the intervention
- •able to download and Inspire smartphone app utilized for clinical compliance information collection
- •Included patients must meet FDA indications for UAS (qualifying apnea-hypopnea index score (AHI), body mass index (AHI) and appropriate anatomical airway collapse pattern as evaluated through clinically required drug induced sleep endoscopy DISE) and be scheduled for UAS implantation in typical clinical care settings at UPMC.
排除标准
- •-engaged in CBT-I in past 6 months
- •does not have access to or unable to use internet capable device (smartphone, tablet or computer)
研究组 & 干预措施
Upfront Digital CBT-i Arm
Digital CBT-i will be delivered prior to Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea
干预措施: Digital Cognitive Behavioral Therapy (CBT-i)-COAST (Device)
Delayed Digital CBT-i Arm
Digital CBT-i will be delivered approximately 3 months after Upper Airway Stimulation activation in patients with comorbid insomnia and obstructive sleep apnea
干预措施: Digital Cognitive Behavioral Therapy (CBT-i)-COAST (Device)
结局指标
主要结局
UAS adherence
时间窗: 1 month, 3 months, and 6 months post-UAS activation
UAS adherence will be measured by average hours of use per night
Change in Insomnia Severity Index (ISI)
时间窗: Change from Baseline at Activation, 1 month, 3 months and 6 months
The Insomnia Severity Index (ISI) is a patient's subjective assessment of their ability to fall and stay asleep. The ISI is a 7 item measure. Answers per item range from 0-4 (0 meaning none/very satisfied-4 meaning very severe/very dissatisfied). Scoring totals range from 0-28. Lower score is better. Higher score suggests worse insomnia.
次要结局
- UAS adherence-overall usage(1 month, 3 months, and 6 months post-UAS activation)
- UAS adherence- % nights with >= 4 hours of usage(1 month post activation, 3 months post activation, and 6 months post activation.)
- UAS average number of pauses per night(1 month post activation, 3 months post activation, and 6 months post activation.)
研究者
Thomas Kaffenberger
Assistant Professor, University of Pittsburgh, Department of Otolaryngology, Division of Sleep Medicine
University of Pittsburgh