UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026601 |
|---|---|
| Receipt number | R000029980 |
| Scientific Title | Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea. |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2017/03/17 20:17:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Acronym
Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Scientific Title
Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Scientific Title:Acronym
Effect of oral appliance on short-term blood pressure variability in patients with obstructive sleep apnea.
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether mild to moderate OSA induce short-term blood pressure variability and the effect of OA therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Apnea Hypopnea Index (AHI), LowestSpO2,blood pressure,short-term blood pressure,immunoreactive insulin(IRI),HbA1c
Key secondary outcomes
Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Observation of changes with OA therapy
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
Individual with mild to moderate OSA(5<AHI<30)
Individual with normal occlusion
Individual with more than 10 teeth in each of upper and lower jaw without severe caries and periodontal disease
Key exclusion criteria
Individual with refusing to cooperation
Individual with already treated with CPAP
Individual with disable to use OA more than four times a week
Individual with starting hypertension treatment during this study
Individual with temporomandibular disorders
Individual with mental health problems
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meiyo Tamaoka |
Organization
Tokyo Medical and Dental University
Division name
Sleep Modulatory Medicine
Zip code
Address
1-5-45 YUshima, Bunkyo-ku, Tokyo
TEL
03-5803-4967
meiyo2.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Meiyo Tamaoka |
Organization
Tokyo Medical and Dental University
Division name
Sleep Modulatory Medicine
Zip code
Address
1-5-45 YUshima, Bunkyo-ku, Tokyo
TEL
03-5803-4967
Homepage URL
meiyo2.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Address
Tel
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
| 2017 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029980
