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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Max Zeller Soehne AG
• Collaborator: University of Basel

Criteria

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