UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043619 |
|---|---|
| Receipt number | 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 00:48:30 |
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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
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
nagasaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
