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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023882
Receipt No. R000027273
Scientific Title Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Date of disclosure of the study information 2016/09/01
Last modified on 2018/03/03

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Basic information
Public title Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Acronym Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Scientific Title Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Scientific Title:Acronym Development of new screening methods for obstructive sleep apnea using perioral muscle activity evaluation
Region
Japan

Condition
Condition obstructive sleep apnea
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the relation of the tongue pressure and apnea hypopnea index of obstructive sleep apnea patients, to confirm the severity factor of sleep apnea.
Basic objectives2 Others
Basic objectives -Others Search of severity factor
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes tongue pressure
Key secondary outcomes apnea hypopnea index

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 Tongue pressure measurement by the tongue pressure measuring instrument for obstructive sleep apnea patients
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 Obstructive sleep apnea patients scheduled for PSG
Key exclusion criteria Patients with secondary abnormalities in maxillofacial form
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Furuhashi Akifumi
Organization Aichi Medical University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 1-1 Yazakokarimata Nagakute Aichi
TEL 0561-62-3311
Email aki0102@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Furuhashi Akifumi
Organization Aichi Medical University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 1-1 Yazakokarimata Nagakute Aichi
TEL 0561-62-3311
Homepage URL
Email aki0102@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University Hospital
Institute
Department

Funding Source
Organization Aichi Medical University Hospital
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
Email

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 愛知医科大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 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
2016 Year 09 Month 01 Day
Last modified on
2018 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027273

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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