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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Drug: Placebo; Drug: Valerian-Hop Extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Baselstadt
    • Basel, Baselstadt, Switzerland, 4055
      • Research Platform MCN University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Max Zeller Soehne AG
• Collaborators: University of Basel
• Investigators: Principal Investigator: Christiane Gerhards, University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Neurocognitive Disorders; Occupational Diseases; Cognition Disorders; Chronobiology Disorders; Sleep Wake Disorders; Cognitive Dysfunction; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: Ze 91019-04-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No