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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-20

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.

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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.

Conditions

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Sleep Disorders, Circadian Rhythm Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double blind, placebo-controlled

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

matching placebo

Study Groups

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Redormin® 500

fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days

Group Type EXPERIMENTAL

Valerian-Hop Extract

Intervention Type DRUG

herbal drug

Placebo

matching placebo, once daily for 21 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Valerian-Hop Extract

herbal drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Redormin® 500

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes