UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051274 |
|---|---|
| Receipt number | R000058482 |
| Scientific Title | Effects of hot springs on sleep |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2025/11/07 09:14:28 |
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Basic information
Public title
Relationship between sleep quality and quality of life in patients with hypertension after night-time hot spring bathing: A single-institution phase II trial
Acronym
SQOL-NHOS
Scientific Title
Effects of hot springs on sleep
Scientific Title:Acronym
EOHSOS
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify a medical program that promotes effective improvement of sleep quality by using hot springs at night, which is effective in suppressing the onset of hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Posthospital sleep assessment (Pittsburgh Sleep Questionnaire, PSQI)
Verify improvement (after 1 month and 3 months).
Key secondary outcomes
Check changes in SF-36 and PSQI(after 1 month and 3 months).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A balneotherapy program for hypertension (From 1 night 2 days to 3 nights 4 days hospitalization) is introduced in hospital.
Interventions/Control_2
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) Those who have been diagnosed with essential hypertension (excluding secondary hypertension) among those who have been diagnosed with hypertension
(2) Those who fully understand this research plan and are able to give their consent
(3) Those who are willing to answer the questionnaire on paper or application
(4) 18 years of age or older at the time of obtaining consent
Key exclusion criteria
(1) Poorly controlled hypertension (systolic blood pressure >160mmHg)
(2) History of acute myocardial infarction, deep vein thrombosis, or pulmonary embolism within 6 months.
(3) Active, advanced stage multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less.
However, lesions equivalent to Carcinoma in situ in the cervix, stomach, and large intestine determined to be cured by local treatment are not included in active double cancer).
(4) Lack of consent, such as dementia.
(5) In addition, the principal investigator or co-investigator is deemed inappropriate to participate in this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
Kyushu University Beppu Hospital
Division name
Department of Internal Medicine
Zip code
874-0840
Address
4546 Tsurumihara, Tsurumi, Beppu, Oita 874-0838, Japan
TEL
0977271640
yamasaki.satoshi.668@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
Kyushu University Beppu Hospital
Division name
Department of Internal Medicine
Zip code
874-0840
Address
4546 Tsurumihara, Tsurumi, Beppu, Oita 874-0838, Japan
TEL
0977271640
Homepage URL
yamasaki.satoshi.668@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Beppu Hospital
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
Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
九州大学病院別府病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058482
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000058482
Number of participants that the trial has enrolled
28
Results
1. Sleep quality improved at 1 and 3 months after nighttime hot spring bathing in older hypertensive patients.
2. Nighttime systolic blood pressure decreased.
3. There was a correlation between improvement in sleep quality and reduction in nocturnal systolic blood pressure.
4. QOL was improved across all eight subscales at 1 month post-intervention, with sustained improvement in mental health at 3 months.
5. EEG analysis demonstrated improvements in sleep architecture after nighttime hot spring bathing.
Results date posted
| 2025 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
The study included 28 older adults (>=65 years) with medication-treated primary hypertension admitted to Kyushu University Beppu Hospital between July 1, 2023 and February 29, 2024.
13 males (46%) and 15 females (54%), with a median age of 75 years (range 68-88).
13 participants (46%) had diabetes mellitus, 11 (39%) had hyperlipidemia, 2 (7%) had arrhythmia, and 2 (7%) had a history of stroke.
19 participants (68%) bathed less than once per month prior to the intervention; 9 (32%) bathed at least once per month.
All participants were independently ambulatory during hospitalization and received a salt-restricted diet supervised by a nutritionist.
Night-time hot spring bathing was conducted for one day (16 participants), two days (8 participants), or three days (4 participants), and EEG monitoring was performed in 12 cases
Participant flow
Between July 1, 2023 and February 29, 2024, 28 patients aged 65 years or older with primary hypertension were enrolled at Kyushu University Beppu Hospital.
Patients with poorly controlled hypertension (SBP>160 mmHg), recent acute myocardial infarction, deep vein thrombosis or pulmonary embolism (within 6 months), active advanced-stage multiple cancers, or incapacity to consent were excluded.
All participants underwent hospitalization for 1-3 days, receiving nighttime chloride hot spring bathing plus lifestyle guidance (exercise and diet). Bathing was conducted for 1 day (16 patients), 2 days (8 patients), or 3 days (4 patients) depending on patient availability.
Overnight portable single-channel EEG monitoring was performed in 12 participants who underwent >=2 consecutive days of bathing.
All participants completed sleep quality and quality of life (SF-36) questionnaires at 1 and 3 months post-intervention.
Data were successfully collected and analyzed for all participants throughout the intervention and at the 3-month follow-up.
Adverse events
Throughout the night-time hot spring bathing intervention and the 3-month follow-up, no serious adverse events (death, hospitalization, life-threatening events, severe disability, etc.) were reported among the 28 participants.
There were no reports of minor complications, such as skin symptoms, accidents during bathing, or drug interactions. All participants safely completed the intervention and evaluations.
No participants discontinued or dropped out due to adverse events during the study.
Outcome measures
Assessed using the Pittsburgh Sleep Quality Index (PSQI, Japanese version) at baseline, 1 month, and 3 months post-intervention.
Evaluated by the SF-36 Health Survey at baseline, 1 month, and 3 months post-intervention, analyzing all eight subscales.
24-hour ambulatory blood pressure monitoring including systolic/diastolic BP, nighttime BP, nocturnal dipping rate, and non-dipper prevalence.
Portable EEG measured sleep latency, total sleep time, REM sleep, non-REM sleep, wake time after sleep onset (WASO), sleep efficiency, delta wave power, etc. (for a subset, n=12).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058482
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/21 | keikakusho2022_温泉プログラム20230509.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/21 | 高血圧の温泉療法プログラム_統計解析計画書20240121.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/02/29 | 高血圧の温泉療法プログラム_総括報告書20240229.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/58482
