PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
详细描述
Patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. Following diagnostic polysomnography (PSG) testing, insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe. Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving optimal therapy at all times during this study. PAP adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use PAP therapy nightly during participation in this protocol. Baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.
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
- Single (Participant)
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
- •Primary complaint of insomnia when presenting at clinic
- •Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
- •Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
- •Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a RDI ≥ 15 events/hour and AHI < 5 events/hour
- •Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB
- •Able to fully understand study information in English and sign informed consent
排除标准
- •Primary complaint of sleep-disordered breathing or issues with apneas during sleep
- •Severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
- •BMI > 30 kg/m2
- •Epworth Sleepiness Scale (ESS) score ≥ 10
- •Frequent napping behavior, such as a few times a week or more
- •Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial
- •Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints
- •Daily use of opiate medications
- •Known contraindications to PAP therapy as listed in the indication for use
- •Requires a CPAP (fixed) pressure > 20 cm H2O
- •Inability to comply with study procedures
结局指标
主要结局
Insomnia Severity Index
时间窗: Baseline and 4 months
Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.
次要结局
- Sleep Onset Latency(4 months)
- Global Morning Rating(4 months)
- Sleep Quality Rating(Baseline and 4 months)
- Wake After Sleep Onset (WASO)(4 months)
- Sleep Efficiency(4 months)