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NCT05684523
Feasibility Study on the Use of Redormin®500 on Day-time Cognition
Conditions: Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 40
Sponsor: Max Zeller Soehne AG
Location: Switzerland
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.
Eligibility Criteria
Inclusion Criteria:HealthyMale or femaleAge: 18-65 years oldOccasional 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 monthFluent in GermanAble and willing to give written informed consent and comply with the requirements of the study protocolExclusion Criteria:DSM-V diagnosis of insomniaHistory of neurologic disorderCurrent psychiatric disorderPresence of moderately severe or severe depressive disorder (PHQ-9 ≥ 15)Current chronic intake of prescription drugs with psychotropic effectsCurrent intake of OTC drugs for sleep or mood problemsPresence of pain conditionDiabetes mellitusCoronary Heart Disease
Source: ClinicalTrials.gov (NCT05684523). StuddyBuddy aggregates publicly available trial information.