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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
herbal drug
Placebo
Research Platform MCN University of Basel
Basel, Canton of Basel-City, Switzerland
Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol
Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey
Time frame: 21 days
Total Sleep Duration Per Day
Total sleep duration as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.
Time frame: each day for 21 days
Total Duration in Bed Per Day
Total duration in bed as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.
Time frame: each day for 21 days
Working Memory at Daytime: Number of Correctly Remembered Digits
The "Digit Span Backward" task was part of the SoSci-Survey as obtained at each day for 21 days. Twelve digits were presented to the participants at each timepoint. Measured were the correctly remembered digits per timepoint (Range 0-12). The outcome reported is based on individual means over 21 days.
Time frame: each day for 21 days
Reaction Time at Daytime
Based on the "Red Button Task" task which was part of the SoSci-Survey as obtained at each day for 21 days. A gray circle was presented on a screen. The circle changed the color to red, and the participants had to push a button as soon as they noticed the change. Reaction time was measured in milliseconds. The outcome reported is based on individual means over 21 days.
Time frame: each day for 21 days
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