UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033572
Receipt No. R000038263
Scientific Title Efficacy of oral muscle function therapy for patients with sleep apnea
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/31

* 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 Efficacy of oral muscle function therapy for patients with sleep apnea
Acronym Oral muscle function therapy in sleep apnea
Scientific Title Efficacy of oral muscle function therapy for patients with sleep apnea
Scientific Title:Acronym Oral muscle function therapy in sleep apnea
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 investigate the effectiveness of oral muscle function therapy for obstructive sleep apnea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Apnea hypopnea index improvement ratio (%)
Key secondary outcomes

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
Behavior,custom
Interventions/Control_1 Oral muscle function therapy is done four times a day for 2 months.
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 1. Age: patients aged 20 years or older at the time of acquiring consent
2. Gender: Male and female
3. cases in which oral devices can not be created
4. Patients who are not allowed to improve AHI in oral devices
5. Patients who can not obtain adherence of intra-oral devices
Key exclusion criteria 1. Patients who can not continue oral muscle function therapy
2. Patients who participated in other clinical studies within 4 months before registration
3. Patients who are deemed inappropriate as research subjects by the research director
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Email syana@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Homepage URL
Email syana@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki 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
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
2018 Year 09 Month 01 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 07 Month 31 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.