Feasibility Study on the Use of Redormin® 500 (Ze 91019) on Day-time Cognition and Quality of Life in People With Occasional Sleep Problems
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of patients completing the study
研究概览
简要总结
Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21 days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological parameters and HRV).
The aim of this study is to determine the feasibility of investigating the effects of Redormin® 500 on day-time cognition and to assess psychological parameters (subjective cognitive performance, tiredness, mood, stress level, quality of life, motivation), in people with occasional sleep problems.
Sleep tracking data will be collected using consumer devices of the Charge series by Fitbit.
详细描述
The overall objective of this study is to evaluate the feasibility of the planned study design and to evaluate the effect of Redormin® 500 on cognitive performance (reaction time, working memory) and psychological parameters with daily measures.
The primary objective of this study is to evaluate the feasibility of the study design to be able to design a confirmatory study.
The secondary objectives are to assess the influence of Redormin® 500 on cognitive performance (reaction time, working memory) and psychological parameters (subjective cognitive performance, stress levels, tiredness, mood, quality of life, and motivation; all of these measures with reference to the current day) with daily measures in the evening, and on sleep parameters and heart rate variability (HRV) as an objective measure for the stress level during day as assessed by the Fitbit tracker.
Safety objectives: Safety will be evaluated by obtaining and analysing adverse events during run-in period and treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
matching placebo
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
- •Age: 18-65 years old
- •Occasional sleep problems (in average 1-2 nights per week, PSQI-score >5) with accompanying subjective cognitive problems (in average at least on one day per week) in the last month
- •Fluent in German
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •DSM-V diagnosis of insomnia
- •History of neurologic disorder
- •Current psychiatric disorder
- •Presence of moderately severe or severe depressive disorder (PHQ-9 ≥ 15)
- •Current chronic intake of prescription drugs with psychotropic effects
- •Current intake of OTC drugs for sleep or mood problems
- •Presence of pain condition
- •Diabetes mellitus
- •Coronary Heart Disease
研究组 & 干预措施
Placebo
matching placebo, once daily for 21 days
干预措施: Placebo (Drug)
Redormin® 500
fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days
干预措施: Valerian-Hop Extract (Drug)
结局指标
主要结局
Percentage of patients completing the study
时间窗: 21 days
Percentage will be calculated by dividing the number of patients completing the study by number of patients interested in the advertisement
次要结局
- Reaction time(each day for 21 days)
- Subjective cognitive performance during the day (visual analogue scale)(each day for 21 days)
- sleep duration(each day for 21 days)