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Completed

NCT Number: NCT05684523

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

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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Key information

Conditions

Sleep Disorders, Circadian Rhythm Chronobiology Disorders Cognition Disorders Cognitive Dysfunction Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Occupational Diseases Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Platform MCN University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valerian-Hop Extract

Drug

herbal drug

Other names: Redormin® 500

Placebo

Drug

Placebo

Primary outcomes

  1. Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol

    Time frame: 21 days

    Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey

Secondary outcomes

  1. Total Sleep Duration Per Day

    Time frame: each day for 21 days

    Total sleep duration as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.

  2. Total Duration in Bed Per Day

    Time frame: each day for 21 days

    Total duration in bed as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.

  3. Working Memory at Daytime: Number of Correctly Remembered Digits

    Time frame: each day for 21 days

    The "Digit Span Backward" task was part of the SoSci-Survey as obtained at each day for 21 days. Twelve digits were presented to the participants at each timepoint. Measured were the correctly remembered digits per timepoint (Range 0-12). The outcome reported is based on individual means over 21 days.

  4. Reaction Time at Daytime

    Time frame: each day for 21 days

    Based on the "Red Button Task" task which was part of the SoSci-Survey as obtained at each day for 21 days. A gray circle was presented on a screen. The circle changed the color to red, and the participants had to push a button as soon as they noticed the change. Reaction time was measured in milliseconds. The outcome reported is based on individual means over 21 days.

Sponsors and collaborators

Lead sponsor

Max Zeller Soehne AG

Industry

Collaborators

  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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