UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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