UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038164 |
|---|---|
| Receipt number | R000043503 |
| Scientific Title | he effect of tongue training using sheet shape supplement on obstructive sleep apnea |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/04/18 10:18:00 |
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Basic information
Public title
The effect of tongue training using sheet shape supplement on obstructive sleep apnea
Acronym
The effect of Tongue training on sleep apnea
Scientific Title
he effect of tongue training using sheet shape supplement on obstructive sleep apnea
Scientific Title:Acronym
The effect of Tongue training on sleep apnea
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology | Oto-rhino-laryngology | Laboratory medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether training using sheet shaped supplement can improve obstructive sleep apnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improve rate of apnea-hypopnea index (AHI) in polysomnography (PSG) after tongue training using sheet shpaed supplement.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Tongue training using sheet shaped supplment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
mild or moderate obstructive sleep apnea
Key exclusion criteria
severe case, mental illness, neuromuscular diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | MIyazaki |
Organization
Tokyo Medical and Dental University
Division name
Respiratory Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
81-3-5803-5954
miyazaki.pilm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Meiyo |
| Middle name | |
| Last name | Tamaoka |
Organization
Tokyo Medical and Dental University
Division name
Respiratory Physiology and Sleep Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
81-3-5803-5954
Homepage URL
meiyou2.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tonguetray Co.,LTD.
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
Tokyo Medicacl and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
Tel
81-3-3813-6111
meiyou2.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | 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
| Delay expected |
Results Delay Reason
Due to COVID-19 pandemic
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043503
