NCT00650871已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of GW679769 (30mg and 90mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Mean Wake time after sleep onset (WASO) derived from PSG recording
研究概览
简要总结
A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female subjects with primary insomnia with normal EG may be eligible for inclusion.
排除标准
- •clinically significant physical or psychiatric illness or abnormal sleep patterns.
结局指标
主要结局
Mean Wake time after sleep onset (WASO) derived from PSG recording
时间窗: Night 1 and 2 of each treatment period (Approximately up to 31 Days)
WASO was measured from persistent sleep onset to lights on. It was calculated as number of wake epochs from persistent sleep onset to lights on divided by 2. WASO measures was analyzed using a mixed effect model with session and treatment as fixed effect and participants as random effect.
次要结局
- Mean wake during sleep (WDS) as objective PSG measures of sleep continuity(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Total Time in REM as objective PSG measures of sleep structure(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- HVLT-R (Retention %) as a measure of daytime Cognitive Function(Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Mean number of 1 minute awakenings during sleep as objective PSG measures of sleep continuity(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Sleep quality (SQ) as parameter of subjective post-sleep questionnaire(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Mean latency to persistent sleep (LPS) as objective PSG measures of sleep continuity(Night 1 and 2 of each treatment period (approximately 31 days))
- Total Time in NREM Stage 1 and stage 2 as objective PSG measures of sleep structure(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Total Time in Slow Wave Sleep (SWS) as objective PSG measures of sleep structure(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Sleep onset latency (SOL) as parameter of subjective post-sleep questionnaire(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Number of awakenings as parameter of subjective post-sleep questionnaire(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Mean total sleep time (TST) as objective PSG measures of sleep continuity(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Latency to REM as objective PSG measures of sleep structure(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- Total sleep time (TST) as parameter of subjective post-sleep questionnaire(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Mean wake after sleep (WAS) as objective PSG measures of sleep continuity(Night 1 and 2 of each treatment period (Approximately up to 31 days))
- WASO as parameter of subjective post-sleep questionnaire(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Digit symbol substitution test (DSST) as a measure of daytime cognitive function(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Leeds Sleep Evaluation Questionnaire as scales for sleepiness/alertness(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Mean Hopkins Verbal Learning Test-Revised (HVLT-R) score including total recall and delayed recall as a measure of Daytime Cognitive Function(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- HVLT-R (Recognition Discrimination Index [RDI]) as a measure of daytime Cognitive Function(Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
- Stanford Sleepiness Scale as scales for sleepiness/alertness(Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days))
研究者
研究点 (8)
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