UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056895 |
|---|---|
| Receipt number | R000065028 |
| Scientific Title | Verification of the effects of cervical pressure techniques on peripheral blood flow and sleep |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 10:08:49 |
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Basic information
Public title
Effects of Neck Massage on Sleep and Blood Flow
Acronym
Neck massage and Sleep
Scientific Title
Verification of the effects of cervical pressure techniques on peripheral blood flow and sleep
Scientific Title:Acronym
Effects of cervical compression on sleep
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to examine the effects of compression techniques applied to the neck and back regions on sleep and blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep architecture
Key secondary outcomes
Skin Blood Flow
Core Body Temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cervical compression technique (30 minutes)
Interventions/Control_2
Lumbar compression technique (30 minutes)
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
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Adult males with low subjective sleep quality (Pittsburgh Sleep Quality Index score from 6 to 12)
Key exclusion criteria
1.Individuals who are currently receiving habitual body treatments such as massage, relaxation therapy, chiropractic care.
2.Shift workers.
3.Individuals undergoing regular medical visits and medication for mental disorders or sleep disorders.
4.Individuals receiving treatment for physical illnesses or injuries.
5.Individuals planning long-term trips or travel across time zones during the intervention period.
6.Heavy smokers (more than 20 cigarettes per day) or individuals who consume alcohol daily (more than 500 mL of beer or more than 180 mL of sake or equivalent).
7.Individuals deemed by the principal investigator to be at risk of health deterioration due to participation in the experiment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
04-2947-6771
nishida@waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Nishida |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
Homepage URL
nishida@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Ethics Review Committee for Research Involving Human Subjects
Address
513 Waseda-Tsurumakicho, Shinjuku, Tokyo 162-0041 JAPAN
Tel
03-5272-1639
rinri@list.waseda.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 | 04 | Month | 01 | 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
| 2024 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065028
