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

Cognitive Dysfunction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684523
• Other study ID #: Ze 91019-04-2022-01
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Max Zeller Soehne AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Drug:
• Valerian-Hop Extract
herbal drug
• Placebo
Placebo

Locations

Country	Name	City	State
Switzerland	Research Platform MCN University of Basel	Basel	Baselstadt

Sponsors (2)

Lead Sponsor	Collaborator
Max Zeller Soehne AG	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reaction time	seconds	each day for 21 days
Secondary	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
Secondary	sleep duration	hours	each day for 21 days