UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038910 |
|---|---|
| Receipt number | R000042963 |
| Scientific Title | The efficacy of oral appliance for blood pressure surge during sleep in patient with obstructive sleep apnea |
| Date of disclosure of the study information | 2019/12/17 |
| Last modified on | 2023/06/20 15:03:44 |
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Basic information
Public title
The efficacy of oral appliance for blood pressure surge during sleep in patient with obstructive sleep apnea
Acronym
Sleep surge study
Scientific Title
The efficacy of oral appliance for blood pressure surge during sleep in patient with obstructive sleep apnea
Scientific Title:Acronym
Sleep surge study
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the efficacy of oral appliance for blood pressure surge in patients with obstructive sleep apnea
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of blood pressure during sleep after one month treatment of oral appliance.
Key secondary outcomes
The change of apnea hypopnea index (AHI) after one month treatment of oral appliance.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Oral appliance treatment (1 month)
Interventions/Control_2
Placebo appliance treatment (1 month)
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
Patients who have been diagnosed with obstructive sleep apnea
Key exclusion criteria
Patients who have a neuromuscular disease, severe heart disease and mental disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Okuno |
| Middle name | |
| Last name | Kentaro |
Organization
Osaka Dental University
Division name
Department of Geriatric Dentistry
Zip code
540-0008
Address
1-5-17, Otemae, Chuo-ku, Osaka, Japan, 540-0008
TEL
06-6910-1050
okuno-kentaro-ig@alumni.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Okuno |
| Middle name | |
| Last name | Kentaro |
Organization
Osaka Dental University
Division name
Department of Geriatric Dentistry
Zip code
540-0008
Address
1-5-17, Otemae, Chuo-ku, Osaka, Japan, 540-0008
TEL
06-6910-1050
Homepage URL
okuno-kentaro-ig@alumni.osaka-u.ac.jp
Sponsor or person
Institute
Department of Geriatric Dentistry, Osaka Dental University
Institute
Department
Personal name
Kentaro OKUNO
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Osaka Dental University
Address
8-1, Kashiwa Hanazonocho, Hirakata, Osaka, Japan, 573-1121
Tel
072-864-3111
okuno-kentaro-ig@alumni.osaka-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
大阪歯科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 17 | 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
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042963
| 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 |
