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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043619
Receipt No. R000048775
Scientific Title To investigate the effect of coaching to reduce weight in patients with obstructive sleep apnea at the start of CPAP treatment
Date of disclosure of the study information 2021/03/22
Last modified on 2021/03/16

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Basic information
Public title To investigate the effect of coaching to reduce weight in patients with obstructive sleep apnea at the start of CPAP treatment
Acronym To investigate the effect of coaching to reduce weight at the start of CPAP treatment
Scientific Title To investigate the effect of coaching to reduce weight in patients with obstructive sleep apnea at the start of CPAP treatment
Scientific Title:Acronym To investigate the effect of coaching to reduce weight at the start of CPAP treatment
Region
Japan

Condition
Condition Obstructive Sleep Apnea
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of life guidance
using telemedicine on CPAP use and body weight decrease in patients with obstructive sleep apnea with initial continuous positive airway pressure (CPAP) use

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decreased body weight more than 3% for 6 months after the initiation of the study
Key secondary outcomes Decreased amount of body weight
Blood pressure at home
Questionnaire score for diet, exercise, and sleep
Results of blood test
Number of records of body weight and blood pressure
CPAP use
and so on

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Life guidance
Interventions/Control_2 No life guidance
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 Patients with obstructive sleep apnea with initiation of continuous positive airway pressure (CPAP) use with obese
and so on
Key exclusion criteria Patients with secondary obesity
Patients on dialysis
Patients with a pacemaker
Patients with difficulty of exercise
Patients using HOT
Patients with dominant CSA
and so on
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Toyohiro
Middle name
Last name Hirai
Organization Kyoto University
Division name Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 0757513830
Email t_hirai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Tadao
Middle name
Last name Nagasaki
Organization Kyoto University
Division name Respiratory Medicine
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3830
Homepage URL
Email nagasaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 C1510
Org. issuing International ID_1 Kyoto University Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 22 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
2021 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 22 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Interventional study

Management information
Registered date
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048775

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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