Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Sleep efficiency
研究概览
简要总结
Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.
详细描述
It is estimated that up to 90% of people will have a sleep concern over their adult life. According to a worldwide survey, one out of two people report unsatisfactory sleep. In Colombia, a Latin American country, more than 60% of adults report sleep concerns. For a long time, positive effects on sleep of plant extracts have been described, and more recently their mechanisms of action and safety have been largely elucidated. This study aims to assess the efficacy and safety of a supplement formulation based on natural products (Saffron, Tea extract, Lemon Balm and Valerian) on objective and subjective sleep parameters.
This is a randomized, doble-blind, placebo controlled clinical trial. The primary outcome is sleep efficiency. A sample size of 60 participants is needed for having a power of 95%, a one type error of 5% and a minimal difference of at least 2.8% between groups in the primary outcome. As we estimate a loss to follow-up of 10%, 66 participants will be enrolled. The main inclusion criteria will be having a poor sleep quality demonstrated as having a Pittsburgh Sleep Quality Index (PSQI) equal to or greater than five. In a random allocation design, one group of participants will receive the active intervention and the other one will receive a placebo with similar organoleptic features. The study will be executed in three main phases: First, a run-in phase where eligible participants will receive the active intervention during one week, and only those with adherence 85% or greater continue to the next phase. Second, a wash-out phase in which participants will not receive any intervention but actigraphic data will be collected. Finally, in the third (intervention) phase participants will be randomized following a minimization algorithm to the active or placebo group, to be taken for six weeks. Subjective and objective sleep variables will be measured at the beginning and the end of the study.
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)
盲法说明
The participants and the investigator who will provide the intervention and collect the data will be masked about interventions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=18, male or female.
- •PSQI >=5
- •Provision of informed consent
- •Adherence >= 85%
排除标准
- •Medical history of a specific sleep disorder according to the DSM-5
- •Taking any specific pharmacologic treatment to improve sleep or planning to take it in the next two months
- •Medical history of generalized anxiety disorder, depression or other serious psychiatric / neurological disease
- •Uncontrolled hypothyroidism
- •Medical history of deficit or excess of corticosteroids (Cushing syndrome, Addison syndrome, chronic steroid use)
- •Alcohol intake (more than two standard drinks/day, on average)
- •Caffeine intake more than 400 mg per day, on average
- •Frequent sleep deprivation over the last two months
- •Women with desire to become pregnant
结局指标
主要结局
Sleep efficiency
时间窗: Baseline (week 0) - Final (week 6)
The change (Week 6 - baseline) in Sleep Efficiency (the ratio of total sleep time to time in bed)
次要结局
- Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality(Baseline (week 0) - Final (week 6))
- Short Form-36 Quality of Life score (SF-36) (0-100), higher score means better quality of life(Baseline (week 0) - Final (week 6))
- Morning salivary cortisol(Baseline (week 0) - Final (week 6))
- Blood creatinine(Baseline (week 0) - Final (week 6))
- Blood alanine amino transferase(Baseline (week 0) - Final (week 6))
研究者
Carlos O Mendivil
Professor of Medicine
University of Los Andes, Columbia