Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Time to fall asleep
研究概览
简要总结
This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.
详细描述
Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females over the age of 18 and below age
- •Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.
排除标准
- •Subjects who have previously taken GABAdone, SentraPM or trazadone.
- •Subjects who are currently taking tricyclic anti-depressants.
- •Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
- •Pregnant or lactating females.
- •Subjects with implanted pacemakers or other implanted electrical devices
研究组 & 干预措施
Sentra PM and trazodone
Active Sentra PM and active trazodone
干预措施: Sentra PM and Trazodone (CoPack Kit Trazamine) (Drug)
Active trazodone and placebo
trazodone 50mg with Sentra PM-like placebo
干预措施: Trazodone (Drug)
placebo and active Sentra PM
Trazodone-like placebo and Sentra PM
干预措施: Sentra PM (Other)
placebo trazodone and placebo Sentra PM
trazadone-like placebo and Sentra PM-like placebo
干预措施: Placebo trazodone and placebo Sentra PM (Drug)
结局指标
主要结局
Time to fall asleep
时间窗: 14 days
Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.
次要结局
- Quality of Sleep(14 days)
- Morning grogginess(14 days)
- Feelings of depression(14 days)
- Feelings of anxiety(14 days)
- Improvement in parasympathetic activity(14 days)