UMIN-CTR Clinical Trial

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