UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058626 |
|---|---|
| Receipt number | R000067039 |
| Scientific Title | The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 06:57:12 |
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Basic information
Public title
The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns
Acronym
The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns
Scientific Title
The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns
Scientific Title:Acronym
The effect of sleep-improving medication administered with a food thickener on nighttime sleep patterns
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of sleep-improving drugs efficacy took with food thickener on nighttime sleep patterns was clarified through objective evaluation using non-contact sleep sensors.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(LPS: Latency to Persistent Sleep):(TST: Total Sleep Time): (SE: Sleep Efficiency):(WASO: Wake After Sleep Onset):
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Using food thickener
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. over 20 years
2. taking Driwell tablets or to be taken Driwell tablets due to temporary insomnia
Key exclusion criteria
1. Patients who are unable to take a water using them mouse
2. Patients who using other hypnotics
3. Patients who are unable to use the sleep sensor by using sofa bed
4. Patients who are unable to make decisions for themselves
5. Patients who are allergic to the food thickener
6. Patients with irregular sleep patterns due to night shifts
7. Patients who share bedding with family or pets and whose sleep patterns cannot be observed
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | yuko |
| Middle name | |
| Last name | sekine |
Organization
Laboratory of Practical Pharmacy, Graduate School and Faculty of Pharmaceutical Sciences, Chiba University
Division name
Laboratory of Practical Pharmacy, Graduate School and Faculty of Pharmaceutical Sciences, Chiba University
Zip code
260-8675
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2109
jitumu-yakugaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Imazeki |
Organization
Laboratory of Practical Pharmacy, Graduate School and Faculty of Pharmaceutical Sciences, Chiba Univ
Division name
Laboratory of Practical Pharmacy, Graduate School and Faculty of Pharmaceutical Sciences, Chiba Univ
Zip code
260-8675
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2109
Homepage URL
jitumu-yakugaku@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Pharmaceutical Sciences Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-226-2852
inohana-soumu2@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067039
