UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052129 |
|---|---|
| Receipt number | R000059498 |
| Scientific Title | Intervention study on the effectiveness of oropharyngeal exercises for Japanese |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2024/05/02 14:53:21 |
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Basic information
Public title
Intervention study on the effectiveness of oropharyngeal exercises for Japanese
Acronym
Intervention study on the effectiveness of oropharyngeal exercises
Scientific Title
Intervention study on the effectiveness of oropharyngeal exercises for Japanese
Scientific Title:Acronym
Intervention study on the effectiveness of oropharyngeal exercises
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of oral exercises for Japanese patients with sleep apnea through a before-and-after comparative study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea Hypopnea Index (AHI)
Key secondary outcomes
Tongue pressure
Lip closure pressure
Snoring frequency
Facial contour
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
| Other |
Interventions/Control_1
Oropharyngeal exercise
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. AHI of 5 or higher on a simple SAS monitor
2. At least 18 years of age at the time of consent
3. Obtained written consent for this study from the subject him/herself
4. LINE application, a Japanese mobile messenger application
Key exclusion criteria
1. Tongue abnormality that makes oral exercises difficult
2. Persons who are judged by the investigator to be unsuitable for this study.
3. People from Europe and North America
4. Performing oral exercises, weight loss, oral appliances, CPAP therapy, etc. for sleep apnea
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783825660
tnagano@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783825660
Homepage URL
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Okuchy corporation
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
Intervention Research Ethics Review Committee
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
kainyu@med.kobe-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
| 2023 | Year | 10 | Month | 30 | 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
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059498
