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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05684523
• Study type: Interventional
• Source: Max Zeller Soehne AG
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2023
• Completion date: December 20, 2023