UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029705 |
|---|---|
| Receipt number | R000033948 |
| Scientific Title | Ramdomized-controlled trial of oral exercise for obstructive sleep apnea syndrome patient who have lower lingual pressure |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2017/10/25 13:20:10 |
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Basic information
Public title
Ramdomized-controlled trial of oral exercise
for obstructive sleep apnea syndrome patient who have lower lingual pressure
Acronym
Ramdomized-controlled trial of oral exercise
for obstructive sleep apnea syndrome patient who have lower lingual pressure
Scientific Title
Ramdomized-controlled trial of oral exercise
for obstructive sleep apnea syndrome patient who have lower lingual pressure
Scientific Title:Acronym
Ramdomized-controlled trial of oral exercise
for obstructive sleep apnea syndrome patient who have lower lingual pressure
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness of two types of oral exercise in the treatment of OSAS and their impact on the reduction of AHI(Apnea Hypopnea Index).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AHI(Apnea Hypopnea Index) after 12weeks from the beginning of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Doing standard oral exercise 30 minitues per day for 12weeks
Interventions/Control_2
Doing oral exercise using tongue training machine 30 minitues per day for 12weeks
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)Patients who is over 20-years-old when wrote informed consent
(2)AHI>5
(3)Patients from whom written informed consent is obtained in this study
(4)Patients whose tongue pressure was lower than 30kPa
Key exclusion criteria
(1)Patients who have severe cardiac disorder
(2)Patients who have dementia
(3)Patients who have severe neuromuscular disorder
(4)Patients who thought to be inadequate
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine,
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5660
tnagano@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reina Sekiya |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine,
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5660
Homepage URL
reina.aoyama@gmail.com
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine,Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2022 | Year | 11 | Month | 30 | 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 | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033948
