Sleep Disorders, Circadian RhythmPhase 4NCT05684523
Feasibility Study on the Use of Redormin®500 on Day-time Cognition
A Phase 4 study testing Valerian-Hop Extract in people with Sleep Disorders, Circadian Rhythm and Cognitive Dysfunction, run by Max Zeller Soehne AG at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction
- What is being tested?
- Valerian-Hop Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 20 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Presence of pain condition
- Diabetes mellitus
- Coronary Heart Disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Research Platform MCN University of Basel
Basel, Canton of Basel-City, 4055
About this study
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
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.
Read the 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.
- Being tested
- Valerian-Hop Extract, Placebo
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valerian-Hop ExtractDrug
Also called Redormin® 500
herbal drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Redormin® 500 | Experimental | fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days Receives: Drug: Valerian-Hop Extract |
| Placebo | Placebo comparator | matching placebo, once daily for 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: each day for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Mar 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Zeller Soehne AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Christiane Gerhards, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684523
- Sponsor's protocol ID
- Ze 91019-04-2022-01
- Status last verified
- May 2026
- First submitted
- 20 Dec 2022
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40462685
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05684523
- Acronym / sponsor ID
- Ze 91019-04-2022-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Max Zeller Soehne AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Basel
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Redormin® 500 | Experimental | Drug: Valerian-Hop Extractfixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days |
| Placebo | Placebo comparator | Drug: Placebomatching placebo, once daily for 21 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valerian-Hop ExtractAlso: Redormin® 500herbal drug | Drug | Redormin® 500 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol
Time frame: 21 days
Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey
4 secondary outcomes
Total Sleep Duration Per Day
Time frame: each day for 21 days
Total Duration in Bed Per Day
Time frame: each day for 21 days
Working Memory at Daytime: Number of Correctly Remembered Digits
Time frame: each day for 21 days
Reaction Time at Daytime
Time frame: each day for 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40462685Schicktanz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Gerhards principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valerian-Hop Extract in people with Sleep Disorders, Circadian Rhythm and Cognitive Dysfunction, run by Max Zeller Soehne AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.