Cognitive Dysfunction, Sleep Disorders, Circadian Rhythm
Conditions
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.
Interventions
DRUGValerian-Hop Extract
herbal drug
DRUGPlacebo
Placebo
Sponsors
Max Zeller Soehne AG
University of Basel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
matching placebo
Intervention model description
randomized, double blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol | 21 days | Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Duration Per Day | each day for 21 days | 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. |
| Total Duration in Bed Per Day | each day for 21 days | 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. |
| Working Memory at Daytime: Number of Correctly Remembered Digits | each day for 21 days | 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. |
| Reaction Time at Daytime | each day for 21 days | 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. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORChristiane Gerhards
University of Basel
Participant flow
Recruitment details
40 healthy volunteers (male and female) between 18 and 65 with occasional sleep problems, defined as sleep disturbances occurring on average 1-2 nights per week, with a Pittsburgh sleep quality index (PSQI) score greater than 5.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Reaction time | 403.74 Milliseconds STANDARD_DEVIATION 93.91 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Sleep parameters Total duration in bed during the night | 7.70 hours STANDARD_DEVIATION 1 |
| Sleep parameters Total sleep duration | 6.76 hours STANDARD_DEVIATION 0.88 |
| Working memory | 8.80 total number of correct responses STANDARD_DEVIATION 2.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 5 / 22 | 9 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 |
Outcome results
None listed