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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033607
Receipt No. R000038313
Scientific Title The effects of telemedicine intervention on weight loss in obese sleep apnea patients with CPAP use
Date of disclosure of the study information 2018/10/01
Last modified on 2019/10/02

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Basic information
Public title The effects of telemedicine intervention on weight loss in obese sleep apnea patients with CPAP use
Acronym Telemedicine for Obese Sleep Apnea Patients study (TMOSAP)study
Scientific Title The effects of telemedicine intervention on weight loss in obese sleep apnea patients with CPAP use
Scientific Title:Acronym Telemedicine for Obese Sleep Apnea Patients study (TMOSAP)study
Region
Japan

Condition
Condition Obesity
Obstructive Sleep Apnea
Classification by specialty
Medicine in general Cardiology Pneumology
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the management of CPAP treatment for sleep apnea patients, telemedicine intervention is helpful to optimize their CPAP treatment adherence. The aim of this study is to evaluate whether telemedicine intervention is effective for not only optimizing CPAP adherence but also losing weight.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The number of patients with more than three percents of weight reduction within 6 months
Key secondary outcomes 1. Weight change in 6 months
2. The number of days with larger calorie consumption than baseline
3. Home blood pressure
4. Scores of the questionnaires for sleep, activity and dietary habits
5. The number of days with weight, blood presure and activity data collection
6. CPAP adherence
7. Blood test (HbA1c,T-cho, HDL-cho,LDL-cho)
8. Number of days with target body weight

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1.The time interval of the patient's visits is extended from 1 or 2 to 3 months.
2.CPAP telemonitoring system is implemented.
3.In the months without patient's visit, the attending physician checks the patient's CPAP adherence once a month by the telemonitoring system.
4. The physician gives a phone call to the patients to optimize their CPAP adherence.
5. The physician provides the weight scale, sphygmomanometer and pedometer to the patient. The physician asks the patient to measure his or her weight, blood pressure and activity level on daily basis at his or her home.
6. Based on the data collected at home, the attending physician instructs the patient to lose his or her weigh on every patient's visit.
Interventions/Control_2 1.The time interval of the patient's visits is extended from 1 or 2 to 3 months.
2.CPAP telemonitoring system is implemented.
3.In the months without patient's visit, the attending physician checks the patient's CPAP adherence once a month by the telemonitoring system.
4. The physician gives a phone call to the patients to optimize their CPAP adherence.
5. The physician provides the weight scale, sphygmomanometer and pedometer to the patient. The physician asks the patient to measure his or her weight, blood pressure and activity level on daily basis at his or her home.
6. Based on the data collected at home, the attending physician instructs the patient to lose his or her weigh on every patient's visit.
7. The attending physician checks the data collected at home every month by telemonitoring system and gives a phone call to lose his or her weight.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Body mass index is more than equal to 25kg/m2
2. Apnea hypopnea index is more than equal to 20/h by polysomnography or Respiratory disturbance index is more than equal to 40/h by portable monitoring device.
3. Visiting the clinic/hospital every month or every two months for the management of CPAP treatment.
4. The attending physician confirmed the patient's CPAP adherence regularly on each patient's visit.
5. Patients owning a smartphone or tablet with Bluetooth function.
Key exclusion criteria 1.Secondary obesity (Obesity because of medication and endocrine disorder)
2.Impaired cognition
3.Chronic diseases affecting body weight (active malignancy and collagen diseases)
4.Dialysis
5.Body weight more than equal to 135kg (Weight scale for measuring at home is not suitable for these patients.)
6.Excercise therapy cannot not recommended (BP >180/100, unstable angina, heart failure, respiratory failure, diabetes with renal failure, stroke and joint pain)
7. Hospitalization is scheduled during the study period
8. New nutritional or excercise therapy are sceduled during the study period for the different purpose from that of the present study
9. The patient who has to see the attending pysician every month or every two months for other reasons than CPAP management
10 Telemedicine intervention has already started
11. Home oxygen therapy
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Chin
Organization Graduate School of Medicine, Kyoto University
Division name Respiratory Care and Sleep Contorol Medicine
Zip code 6068507
Address 54 Kawaharacho Sakyo Kyoto Japan
TEL (+81)757513852
Email enkaku@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Murase
Middle name
Last name Kimihiko
Organization Graduate School of Medicine, Kyoto University
Division name Respiratory Care and Sleep Contorol Medicine
Zip code 6068507
Address 54 Kawaharacho Sakyo Kyoto Japan
TEL (+81)757513852
Homepage URL
Email enkaku@kuhp.kyoto-u.ac.jp

Sponsor
Institute Respiratory Care and Sleep Contorol Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Health , Labour and Welfare Sciences Research Grants, Research on Region Medical (H30-iryou-ippan-009)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor 1.Tohoku university Hospital
2.Fukushima Medical University Hospital
3.Jichi Medical University Hospital
4.Juntendo University Hospital
5.Nihon university Hospital
6.Tokyo Medical University Hospital
7.Jikei Medical universtiy Hospital
8.Shinjuku Sleep and Respiratory Clinic
9.Toranomon Hospital
10. Chiba University Hospital
11. Nishi-Niigata Chuo National Hospital
12. National Hospital Organization Minami Kyoto Hospital
13. Takatsuki Red Cross Hospital
14. Osaka Kaisei Hospital
15. Nara Medical University Hospital
16. Kobe City Medical Center General Hospital
17. Tottori University Hospital
18. Kyushu university Hospital
19. Kirigaoka Tsuda Hospital
20. Inoue Hospital, Shunkaikai
21. Nakamura Clinic
22. Ureshinogaoka Samaritan Hospital
23. KKR Takamatsu Hospital
24 Kawasaki Medical University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Hospital Ethics Committee
Address 54 Kawaharacho Sakyo Kyoto Japan
Tel 81-75-753-4680
Email ethcom@kuhp.kyoto-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
2018 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 10 Month 22 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 02 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038313

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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