UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041489 |
|---|---|
| Receipt number | R000047368 |
| Scientific Title | Effects of tongue strength training on patients with sleep-disordered breathing: A randomized controlled trial |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2020/11/02 10:26:27 |
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Basic information
Public title
Effects of tongue strength training on patients with sleep-disordered breathing: A randomized controlled trial
Acronym
Effects of tongue strength training on patients with sleep-disordered breathing: A randomized controlled trial
Scientific Title
Effects of tongue strength training on patients with sleep-disordered breathing: A randomized controlled trial
Scientific Title:Acronym
Effects of tongue strength training on patients with sleep-disordered breathing: A randomized controlled trial
Region
| Japan |
Condition
Condition
sleep-disordered breathing
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether tongue strength training for 2 months improves apnea hypopnea indexes in patients with sleep-disordered breathing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of apnea hypopnea index from baseline after 2 months of tongue strength training
Key secondary outcomes
The changes of ESS (Epworth Sleepiness Scale), minimum SpO2 during sleep, tongue pressure and neck circumference after 2 months of tongue strength training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 |
Interventions/Control_1
Tongue pressure training for 2 months using a tongue pressure training tool
Interventions/Control_2
No treatment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who are visiting Kobe University Hospital and has mild-to-moderate sleep-disordered breathing (AHI of 5-30)
2. Patients who have not been treated for sleep-disordered breathing for the past year
3. Patients who have consented to participate in this study
Key exclusion criteria
1. Patients with severe heart disease
2. Patients with dementia
3. Patients with severe neuromuscular disease
4. Patients with tongue movement disorder due to cerebrovascular disorder
5. Patients who were judged unsuitable by doctors in charge of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nishimura |
Organization
Kobe university hospital
Division name
Division of respiratory medicine
Zip code
650-0017
Address
7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5660
nishiy@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe university hospital
Division name
Division of respiratory medicine
Zip code
650-0017
Address
7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5660
Homepage URL
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe university hospital
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
Kobe university hospital clinical and translational research center
Address
7-5-2 Kusunokicho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
| 2020 | 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
| 2020 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047368
