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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041489 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | sleep-disordered breathing | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kobe university hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047368 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |