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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035476
Receipt No. R000039813
Scientific Title Myofunctional therapy effective for obstructive sleep apnea in elderly patients
Date of disclosure of the study information 2019/01/08
Last modified on 2019/01/07

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Basic information
Public title Myofunctional therapy effective for obstructive sleep apnea in elderly patients
Acronym MFT effective for elderly OSA patients
Scientific Title Myofunctional therapy effective for obstructive sleep apnea in elderly patients
Scientific Title:Acronym MFT effective for elderly OSA patients
Region
Japan

Condition
Condition obstructive sleep apnea
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a new myofunctional therapy effective for elderly OSA patients
Basic objectives2 Others
Basic objectives -Others To evaluate the change in the expression of a particular miRNA
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes portable sleep monitor, polysomnography, serum miRNA
Key secondary outcomes cognitive function, motor function, Periodic Repolarization Dynamics(PRD)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 exercise using 'Fukimodoshi': a Japanese whistle, which is ususally used as a toy for children
Interventions/Control_2 exercise using a device for exercise of the tonguel, which is used to prevent aspiration pneumonia
Interventions/Control_3 pronoucing vowels, elevation of the mouth muscles, suction movements
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients 65 years and older who are attending the Geriatrics and General medicine at Osaka University, and who were suspected and diagnosed as OSA.
Key exclusion criteria Patients with cognitive impairment, those under hyperdialysis, those with more CSA than OSA
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Hongyo
Organization Osaka Unioversity
Division name Geriatrics and General medicine
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka
TEL 0668793852
Email khongyo@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Hongyo
Organization Osaka Unioversity
Division name Geriatrics and General medicine
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka
TEL 0668793852
Homepage URL
Email khongyo@geriat.med.osaka-u.ac.jp

Sponsor
Institute Osaka Unioversity
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 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
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
2018 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 02 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
2019 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039813

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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