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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038910
Receipt No. 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 2019/12/17

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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
Email 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
Email okuno-kentaro-ig@alumni.osaka-u.ac.jp

Sponsor
Institute Department of Geriatric Dentistry, Osaka Dental University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
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 The ethics committee of Osaka Dental University
Address 8-1, Kashiwa Hanazonocho, Hirakata, Osaka, Japan, 573-1121
Tel 072-864-3111
Email 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
2022 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
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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