UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047151 |
|---|---|
| Receipt number | R000053789 |
| Scientific Title | Sleep facilitation by Artificial carbonated bathing in healthy elderly. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/11 18:46:27 |
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Basic information
Public title
Sleep facilitation by Artificial carbonated bathing in healthy elderly.
Acronym
Sleep facilitation by Artificial carbonated bathing in healthy elderly.
Scientific Title
Sleep facilitation by Artificial carbonated bathing in healthy elderly.
Scientific Title:Acronym
Sleep facilitation by Artificial carbonated bathing in healthy elderly.
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of artificial carbonated bathing on sleep in healthy elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG, proximal and distal temperature after bating
Key secondary outcomes
VAS(visual analog scale),CFF(critical flicker fusion)test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Artificial carbonated bathing,30 degree 10min,1time
Interventions/Control_2
normal(plain hot water)bathing,30 degree,10min,1time
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To be in good health as confirmed by their medical history and physical examination.
The subjects agreed to avoid physical activity that was strenuous or physical activity they were unaccustomed to during the study.
Key exclusion criteria
Use of hypnotics within the previous year and a history of drug or alcohol abuse.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Uemura |
Organization
Akita University Graduate School of Medicine
Division name
Department of Physical Therapy
Zip code
010-8543
Address
+81-18-884-6529
TEL
018-884-6529
uemura@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Uemura |
Organization
Akita University Graduate School of Medicine
Division name
Department of Physical Therapy
Zip code
010-8543
Address
1-1-1 Hondo, Akita-city, Akita
TEL
018-884-6529
Homepage URL
uemura@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Graduate School of Medicine, Akita, Japan
Address
1-1-1 Hond Akita-city Akita
Tel
018-884-6500
soken@hos.akita-u.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
| 2022 | 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
10
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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053789
