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

Max Zeller Söhne

Status and phase: Completed; Phase 4

Conditions: Cognitive Dysfunction; Sleep Disorders, Circadian Rhythm

Treatments: Drug: Valerian-Hop Extract; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05684523

Ze 91019-04-2022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Redormin® 500

Experimental group

Description:

fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days

Treatment:

Drug: Valerian-Hop Extract

Placebo

Placebo Comparator group

Description:

matching placebo, once daily for 21 days

Treatment:

Drug: Placebo