UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055766 |
|---|---|
| Receipt number | R000063738 |
| Scientific Title | The Effect of Acupuncture Stimulation on Sleep Quality in University Students with Sleep Problems |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/07 19:00:46 |
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Basic information
Public title
The Effect of Acupuncture Stimulation on Sleep Quality in University Students with Sleep Problems
Acronym
The Effect of Acupuncture Stimulation on Sleep Quality in University Students with Sleep Problems
Scientific Title
The Effect of Acupuncture Stimulation on Sleep Quality in University Students with Sleep Problems
Scientific Title:Acronym
The Effect of Acupuncture Stimulation on Sleep Quality in University Students with Sleep Problems
Region
| Japan |
Condition
Condition
Persons with sleep problems
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjective and Objective Evaluation of the Effect of Acupuncture Treatment on Sleep Quality in University Students with Sleep Problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restorative sleep Questionnaire Japanese version(RSQ-W-J)
Key secondary outcomes
OSA Sleep Inventory, Sleep Stages, Salivary Cortisol, Melatonin, Sleep-Related Heart Rate, Skin Temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture therapy
Interventions/Control_2
control
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who have no apparent organic disease on physical examination.
2. Those with an Insomnia Severity Index (ISI) of 8 or more points.
Key exclusion criteria
1. Those who are receiving hospitalization or medication
2. Those who are participating in other clinical trials or clinical studies at the same time
3. Those who live day and night in reverse due to work or part-time job.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Waki |
Organization
University of Teikyoheise Faculty of Health Care
Division name
Department of acupuncture and Moxibustion
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL
035-843-3111
h.waki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Waki |
Organization
University of Teikyoheise Faculty of Health Care
Division name
Department of acupuncture and Moxibustion.
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL
035-843-3111
Homepage URL
h.waki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei 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
Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo 170-8445, Japan
Tel
03-5843-3111
rec@thu.ac.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
| 2024 | Year | 10 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063738
