UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053095 |
|---|---|
| Receipt number | R000060589 |
| Scientific Title | Tongue training on body composition, body weight, oral commensal flora, and hormones in patients with obstructive sleep apnea |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2023/12/13 20:37:32 |
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Basic information
Public title
Tongue training on body composition, body weight, oral commensal flora, and hormones in patients with obstructive sleep apnea
Acronym
Tongue training in patients with obstructive sleep apnea
Scientific Title
Tongue training on body composition, body weight, oral commensal flora, and hormones in patients with obstructive sleep apnea
Scientific Title:Acronym
Tongue training in patients with obstructive sleep apnea
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
| Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment of obstructive sleep apnea (OSA) is thought to have the potential to improve obesity. OSA is also known to induce changes in the flora of oral commensal bacteria, and these changes have been linked to obesity. The purpose of this study is to investigate the effects of tongue training on body composition and oral microflora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition, tongue pressure, apnea status, pharyngeal status, changes in oral flora, and serum appetite hormone levels will be compared before and after 12 weeks of tongue training. A questionnaire on eating behavior will be administered before and after, and this will also be compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Tongue training instruction
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
Adult obstructive sleep apnea patients who requested tongue training instruction and consented to the study
Key exclusion criteria
Patients who are under 18 years old.
Patients who have difficulty in understanding and making adequate judgments.
Patients whose general condition is so deteriorated that participation in the study is considered difficult.
Patients who are judged by the principal investigator/researcher to be inappropriate to participate in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Tateishi |
Organization
Tokyo Medical and Dental University
Division name
Department of Respiratory Physiology and Sleep Medicine
Zip code
113-0034
Address
1-5-45, Yushuma, Bunkyo-ku, Tokyo, Japan
TEL
0358035954
tateishi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Sonoda |
Organization
Tokyo Medical and Dental University
Division name
Department of Respiratory Medicine
Zip code
113-0034
Address
1-5-45, Yushuma, Bunkyo-ku, Tokyo, Japan
TEL
0358035954
Homepage URL
sonoda.shiro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
donation for research
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
Medical ethics review board of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
0338136111
tateishi.pulm@tmd.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
東京医科歯科大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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 | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
