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Feasibility Study on the Use of Redormin®500 on Day-time Cognition

Primary Purpose

Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction

Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Valerian-Hop Extract
Placebo
Sponsored by
Max Zeller Soehne AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Disorders, Circadian Rhythm

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Platform MCN University of BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Redormin® 500

Placebo

Arm Description

fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days

matching placebo, once daily for 21 days

Outcomes

Primary Outcome Measures

Percentage of patients completing the study
Percentage will be calculated by dividing the number of patients completing the study by number of patients interested in the advertisement

Secondary Outcome Measures

Reaction time
seconds
Subjective cognitive performance during the day (visual analogue scale)
minimum value 1, maximum value 101, higher value means better cognitive performance
sleep duration
hours

Full Information

First Posted
December 20, 2022
Last Updated
June 28, 2023
Sponsor
Max Zeller Soehne AG
Collaborators
University of Basel
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1. Study Identification

Unique Protocol Identification Number
NCT05684523
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Zeller Soehne AG
Collaborators
University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm, Cognitive Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double blind, placebo-controlled
Masking
ParticipantInvestigator
Masking Description
matching placebo
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Redormin® 500
Arm Type
Experimental
Arm Description
fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo, once daily for 21 days
Intervention Type
Drug
Intervention Name(s)
Valerian-Hop Extract
Other Intervention Name(s)
Redormin® 500
Intervention Description
herbal drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of patients completing the study
Description
Percentage will be calculated by dividing the number of patients completing the study by number of patients interested in the advertisement
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Reaction time
Description
seconds
Time Frame
each day for 21 days
Title
Subjective cognitive performance during the day (visual analogue scale)
Description
minimum value 1, maximum value 101, higher value means better cognitive performance
Time Frame
each day for 21 days
Title
sleep duration
Description
hours
Time Frame
each day for 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christiane Gerhards, MD
Phone
+41 61 207 0244
Email
christiane.gerhards@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Gerhards
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Platform MCN University of Basel
City
Basel
State/Province
Baselstadt
ZIP/Postal Code
4055
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Gerhards, MD
Phone
+41 61 207 0244
Email
christiane.gerhards@unibas.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility Study on the Use of Redormin®500 on Day-time Cognition

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