UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042047 |
|---|---|
| Receipt number | R000047987 |
| Scientific Title | Influences of tongue position controller on obstructive sleep apnea |
| Date of disclosure of the study information | 2020/10/08 |
| Last modified on | 2021/04/13 07:02:35 |
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Basic information
Public title
Influences of tongue position controller on obstructive sleep apnea
Acronym
Tongue position and obstructive sleep apnea
Scientific Title
Influences of tongue position controller on obstructive sleep apnea
Scientific Title:Acronym
Tongue position and obstructive sleep apnea
Region
| Japan |
Condition
Condition
Adult patients diagnosed with obstructive sleep apnea by polysomnography
Classification by specialty
| Medicine in general | Pneumology | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that obstructive sleep apnea could be alleviated if the tongue position is maintained through the use of a tongue position controller
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Apnea Hypopnea Index (AHI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Tongue position controller
Interventions/Control_2
Mandibular advancement device
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients with mild to moderate obstructive sleep apnea
Key exclusion criteria
Patients with insomnia, severe comorbidities, severe periodontitis, temporomandibular joint disorders
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | TSUIKI |
Organization
Institute of Neuropsychiatry
Division name
Reserach Department
Zip code
162-0851
Address
91, Bentencho, Shinjuku, Tokyo
TEL
03-3944-2255
strtsuiki@gmail.com
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | TSUIKI |
Organization
Institute of Neuropsychiatry
Division name
Research Department
Zip code
162-0851
Address
91, Bentencho, Shinjuku, Tokyo
TEL
03-3944-2255
Homepage URL
strtsuiki@gmail.com
Sponsor or person
Institute
Institute of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Institute of Neuropsychiatry
Address
91, Bentencho, Shinjuku, Tokyo, Japan
Tel
03-3944-2255
office.admin@ionp.or.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
| 2020 | Year | 10 | Month | 08 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047987
