NCT01804907已完成不适用
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Sleep Efficiency
研究概览
简要总结
To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study;
- •males or females age 18-75 years of age;
- •≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD;
- •sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary);
- •be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period.
排除标准
- •use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics;
- •history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
- •clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
- •self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1);
- •have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study;
- •unable to give informed consent or comply with study procedures.
结局指标
主要结局
Sleep Efficiency
时间窗: Week 1, 2,3, and 4
Patients evaluated weekly for change in sleep efficiency.
次要结局
- Adherence to HAART(Week 1, 2,3, and 4)
- Fatigue(Week 1, 2,3, and 4)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Non-pharmacological Treatment of Insomnia in Nursing Homes.InsomniaNCT01091987University Ghent45
已完成
不适用
Non-Pharmacological Interventions on Sleep in Post-Acute RehabilitationSleep DisordersNCT00333619US Department of Veterans Affairs219
已完成
不适用
Non-deceptive Application of Placebos in InsomniaInsomniaNCT03616652Philipps University Marburg Medical Center51
已完成
不适用
The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep ProblemsBipolar Affective DisorderAttention Deficit DisorderDepressionNCT05406414University of Aarhus88
已完成
不适用
Survivorship Sleep ProgramCancerInsomniaNCT04566068Massachusetts General Hospital40