Feasibility Study on the Use of Redormin®500 on Day-time Cognition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility Study on the Use of Redormin® 500 (Ze 91019) on Day-time Cognition and Quality of Life in People With Occasional Sleep Problems

Conditions
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Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction

Intervention / Treatment
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* Drug: Valerian-Hop Extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double blind, placebo-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Redormin® 500<br>fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days | Drug: Valerian-Hop Extract<br>* herbal drug<br>* Other names: Redormin® 500;|
| Placebo Comparator: Placebo<br>matching placebo, once daily for 21 days | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients completing the study | Percentage will be calculated by dividing the number of patients completing the study by number of patients interested in the advertisement | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time | seconds | each day for 21 days | 
| Subjective cognitive performance during the day (visual analogue scale) | minimum value 1, maximum value 101, higher value means better cognitive performance | each day for 21 days | 
| sleep duration | hours | each day for 21 days |