UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062184 |
|---|---|
| Receipt number | R000063233 |
| Scientific Title | Evaluation of the Effectiveness of Sleep Quality Improvement through Lifestyle Improvement Support at Community Pharmacies Using Sleep Digital Biomarkers: A randomized controlled trial |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/09 09:40:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effectiveness of Sleep Quality Improvement through Lifestyle Improvement Support at Community Pharmacies Using Sleep Digital Biomarkers
Acronym
COMPASS-Insomnia
Scientific Title
Evaluation of the Effectiveness of Sleep Quality Improvement through Lifestyle Improvement Support at Community Pharmacies Using Sleep Digital Biomarkers: A randomized controlled trial
Scientific Title:Acronym
COMPASS-Insomnia
Region
| Japan |
Condition
Condition
Sleep Disorder, Insomnia
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of improving sleep quality by providing lifestyle modification support based on sleep hygiene and health behavioral science by pharmacists in community pharmacies for persons with insomnia, using digital biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep Quality: Differences in sleep efficiency, Athens Insomnia Scale score, and RU-SATED score between the two groups from baseline at start to 3 months
Key secondary outcomes
Patients: time to bed, time to fall asleep, time to rise from bed, sleep duration, time to fall asleep, time to fall asleep, time to fall asleep, time to wake up in the middle of the day, activity level
Pharmacists: knowledge, confidence, and attitude about sleep hygiene practices
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep hygiene and behavior science skills by pharmacists in community pharmacies.
Interventions/Control_2
Usual care
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing sleep treatment with medications.
2) Patients age 18 years and older.
3) Patients who can use a sleep device during the study period.
Key exclusion criteria
1) Patients with prescriptions for psychiatric or anti-dementia medications.
2) Patients who have difficulty participating in the study on a continuous basis (approximately 3 months).
3) Patients who are employed in shift work
4) Patients who are judged by the principal investigator to be inappropriate as research participants.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
Wakayama Medical University
Division name
School of Pharmaceutical Sciences
Zip code
640-8156
Address
25-1 Nanabancho Wakayama
TEL
073-488-1843
okada_h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okada |
Organization
Wakayam Medical University
Division name
School of Pharmaceutical Sciences
Zip code
640-8156
Address
25-1Nanabancho Wakayama
TEL
073-488-1843
Homepage URL
okada.hiroshi.28z@kyoto-u.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Health Organization, Kyoto Medical Center
Address
1-1 Fushimi-ku Fukakusa Mukaihata-cho, Kyoto
Tel
075-641-9161
bufobufo.ok@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
23-077
Org. issuing International ID_1
Kyoto Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
エバグリーン薬局（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 10 | 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
86
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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063233
