A Study to Evaluate the Effects of the Speed Sleep Supplement on Sleep Quality and Quantity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Sleep Score
研究概览
简要总结
This study evaluates the effects of the Speed Sleep supplement on sleep quality and quantity in adults aged 18-65 years. Participants will be randomized to receive either the supplement or placebo for 4 weeks, with outcomes assessed using Fitbit sleep tracking data and questionnaires.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 18-65
- •Experiencing issues with sleep (falling asleep, staying asleep)
- •Generally healthy
- •Willing to discontinue sleep-related supplements
- •Maintain consistent sleep patterns
- •Resides in the United States
排除标准
- •Chronic medical or sleep disorders
- •Use of sleep medications
- •Hormone therapy or anticoagulants
- •Heavy alcohol use
- •Night shift workers
- •Pregnancy or breastfeeding
- •Smoking or substance abuse
- •Allergies to ingredients
研究组 & 干预措施
Speed Sleep Supplement
Participants receive Speed Sleep supplement daily for 4 weeks.
干预措施: Dietary Supplement: Speed Sleep (Dietary Supplement)
Placebo
Participants receive placebo capsules daily for 4 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Sleep Score
时间窗: Baseline and Week 4
Assessed using Fitbit-generated sleep score reflecting overall sleep quality. Higher scores indicate better sleep quality.
Change in Total Sleep Time
时间窗: Baseline and Week 4
Measured using Fitbit as total time asleep during the night.
Change in Time Awake During Sleep Period
时间窗: Baseline and Week 4
Measured using Fitbit as total time awake during the sleep period.
Change in Number of Awakenings
时间窗: Baseline and Week 4
Measured using Fitbit as number of awakenings during the sleep period.
Change in Deep Sleep Duration
时间窗: Baseline and Week 4
Measured using Fitbit as time spent in deep sleep stages.
Change in REM Sleep Duration
时间窗: Baseline and Week 4
Measured using Fitbit as time spent in REM sleep stages.
Change in Sleep Quality Score (SQS)
时间窗: Baseline, Week 1, Week 2, Week 3, Week 4
Assessed using the validated Sleep Quality Score (SQS) questionnaire. Scores reflect subjective sleep quality, with changes over time indicating improvement or decline.
次要结局
- Change in Sleep Latency(Baseline, Week 1, Week 2, Week 3, Week 4)
- Change in Self-Reported Anxiety Levels(Baseline, Week 1, Week 2, Week 3, Week 4)
- Change in Self-Reported Level of Relaxation(Baseline, Week 1, Week 2, Week 3, Week 4)