Clinical trial NCT05684523: Feasibility Study on the Use of Redormin®500 on Day-time Cognition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disorders, Circadian Rhythm
Cognitive Dysfunction
Lead sponsor: Max Zeller Soehne AG
Sponsor class: INDUSTRY
Collaborators: name: University of Basel
First posted: 2023-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind, placebo-controlled
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients completing the study
timeFrame: 21 days
Secondary outcomes:
measure: Reaction time
timeFrame: each day for 21 days
measure: Subjective cognitive performance during the day (visual analogue scale)
timeFrame: each day for 21 days
measure: sleep duration
timeFrame: each day for 21 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Research Platform MCN University of Basel
state: Baselstadt
Study officials:
affiliation: University of Basel
name: Christiane Gerhards
role: PRINCIPAL_INVESTIGATOR
References: