UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052902 |
|---|---|
| Receipt number | R000060360 |
| Scientific Title | Validation of the Efficacy of Non-Invasive Tongue Position Correction for obstructive sleep apnea |
| Date of disclosure of the study information | 2023/11/25 |
| Last modified on | 2023/11/25 15:41:04 |
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Basic information
Public title
Validation of the Efficacy of Non-Invasive Tongue Position Correction for obstructive sleep apnea
Acronym
Tongue Position Correction for sleep apnea
Scientific Title
Validation of the Efficacy of Non-Invasive Tongue Position Correction for obstructive sleep apnea
Scientific Title:Acronym
Efficacy of noninvasive tongue position correction for obstructive sleep apnea
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obstructive sleep apnea (OSA) impacts life prognosis, making its improvement a paramount concern. However, conventional treatments such as continuous positive airway pressure (CPAP) and oral appliances (OA) pose inherent issues, necessitating the exploration of novel therapeutic approaches. The current state underscores the need for the development of alternative treatments. The purpose of this study is to accumulate further scientific evidence in a sufficient number of patients in order to develop a novel and curative treatment for sleep apnea by noninvasive tongue positioning correction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea hypopnea index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Tongue positioner
Interventions/Control_2
Myofanctional therapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Age between 20 and 75 years old
(2) Patients diagnosed with mild to moderate obstructive sleep apnea on polysomnography at all-night examination (apnea-hypopnea index 5 to 30/hr)
(3) Patients who have given their consent to participate in this study in writing of their own free will after full
Key exclusion criteria
(1)Central apnea (>10% of total AHI)
(2) Severe temporomandibular joint disorder, mandibular retraction (diagnosed by dental surgery)
(3) Severe nasal breathing disorder due to nasal sinus disease (e.g., nasal septal deformity, nasal polyps)
(4) Cases in which the posterior space of the molars (wisdom teeth) is less than 2 mm
(5) Shortening of the lingual frenulum
(6) Cases with strong vomiting reflex
(7) Enlarged palatine tonsils (Brodsky's 4th degree)
(8) Chronic obstructive pulmonary disease
(9) When a subject requests to withdraw from participation in the research or withdraws patients consent
(10) Other subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
113-8421
Address
3-1-3Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1584
ayaent@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
113-8421
Address
3-1-3Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1584
Homepage URL
ayaent@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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 | 11 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | 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 | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060360
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