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| Name | Class |
|---|---|
| University of Basel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redormin® 500 | Experimental | fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days |
|
| Placebo | Placebo Comparator | matching placebo, once daily for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valerian-Hop Extract | Drug | herbal drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | each day for 21 days |
| Total Duration in Bed Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Gerhards | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Platform MCN University of Basel | Basel | Canton of Basel-City | 4055 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40462685 | Result | Schicktanz N, Gerhards C, Schlitt T, Aerni A, Muggler E, de Quervain D, Papassotiropoulos A, Boonen G, Drewe J, Butterweck V. Effects of a Valerian-Hops Extract Combination (Ze 91019) on Sleep Duration and Daytime Cognitive and Psychological Parameters in Occasional Insomnia: A Randomized Controlled Feasibility Trial. Brain Behav. 2025 Jun;15(6):e70600. doi: 10.1002/brb3.70600. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days |
| FG001 | Verum (Ze 91019) | 18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days |
| BG001 | Verum (Ze 91019) | 18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age in years at the timepoint of study enrolment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Participants | 21 days |
|
Adverse events as collected during the treatment phase of 21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 22 healthy volunteers receiving placebo | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Veronika Butterweck | Max Zeller Soehne AG | +41714660447 | veronika.butterweck@zellerag.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2023 | Apr 23, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2024 | Apr 23, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C039603 | Hova |
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randomized, double blind, placebo-controlled
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matching placebo
| Placebo | Drug | Placebo |
|
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.
| 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. | 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. | each day for 21 days |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Sex in categories female and male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Sleep parameters | Sleep parameters as recorded by Fitbit device. Baseline characteristics were summarized by randomized group only. No pooled analyses across treatment groups were performed; Total values are therefore not available. The values entered unter Total are means of the respective values of the two study groups. | Mean | Standard Deviation | hours |
|
| Working memory | Measured by "Digit Span Backward" in the SoSci-Survey. Baseline characteristics were summarized by randomized group only. No pooled analyses across treatment groups were performed; Total values are therefore not available. The values entered unter Total are means of the respective values of the two study groups. | Mean | Standard Deviation | total number of correct responses |
|
| Reaction time | Measured by "Red Button Task" in the SoSci-Survey. Baseline characteristics were summarized by randomized group only. No pooled analyses across treatment groups were performed; Total values are therefore not available. The values entered unter Total are means of the respective values of the two study groups. | Mean | Standard Deviation | Milliseconds |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours per day | each day for 21 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours per day | each day for 21 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of correct responses per day | each day for 21 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | milliseconds per individual test | each day for 21 days |
|
|
|
| 22 |
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | Verum (Ze 91019) | 18 healthy volunteers receiving verum (Ze 91019) | 0 | 18 | 0 | 18 | 9 | 18 |
| Viral rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Flu-like infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Covid-19 infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bladder irritation | Renal and urinary disorders | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |