Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in sleep latency, wake after sleep onset, sleep efficiency; efficacy of modafinil and the combination of modafinil and CBT-I on previously mentioned outcome measures
研究概览
简要总结
This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the severity of insomnia.
详细描述
Our primary goal is to undertake a 2nd study evaluating whether Modafinil, alone or in combination with behavioral treatment for insomnia, will improve subjects' sleep continuity and/or self report daytime function.
METHODS AND PROCEDURES
Schedule for Procedures.
Screening interview Sleep over night in our lab for one night 8 weeks of either behavioral or psychological therapy for insomnia 3 month post therapy follow up (two weeks of sleep diaries and one lab visit)
40 patients aged 25-80 with insomnia. All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM. The age range is restricted to 1) minimize circadian rhythm influences on the diagnoses of Psychophysiological insomnia, 2) to increase our ability to recruit medically healthy sample, and 3) increase sample homogeneity.
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
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 patients aged 25 with insomnia, will be recruited over a 3-6 month interval.
- •All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM.
- •Must live in the Greater Rochester NY area
- •All subjects will meet diagnostic criteria for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). Criteria are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake.
排除标准
- 未提供
结局指标
主要结局
Change in sleep latency, wake after sleep onset, sleep efficiency; efficacy of modafinil and the combination of modafinil and CBT-I on previously mentioned outcome measures
次要结局
- Long term (3 months) effects of treatment