UMIN-CTR Clinical Trial

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
Email	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
Email	uemura@hs.akita-u.ac.jp

Sponsor
Institute	Akita University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053789