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Name:
UMIN ID:

Recruitment status Completed
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 2021/09/18

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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 participants who achieved 3% weight reduction within the observational period.
Key secondary outcomes 1. Weight change within the observational period
2. Number of steps within the observational period
3. Office and Home blood pressure
4. Scores of the questionnaires for sleep, activity and dietary habits
5. Number of days that the participants collected the data of their weight, blood pressure and pedometer at home
6. CPAP adherence
7. Blood test (HbA1c,T-cho, HDL-cho,LDL-cho, Liver enzyme)
8. Number of days that the participants achieved their target weight within the observational period

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 Multimodal-telemonitoring Group
1. At the baseline visit, mobile health (mHealth) devices, namely the electrical weight scale, sphygmomanometer and pedometer will be provided to a participant. Attending physician will ask each participant to measure his or her weight, blood pressure and the number of steps on daily basis at home for self-monitoring. Further, the participant will be instructed to transmit the data to the mHealth telemonitoring system using their own smartphone and a dedicated mobile application. The Participant can confirm the obtained data anytime with his or her own smartphone.
2. The time interval of the visits will be extended from 1 or 2 to 3 months.
3. CPAP telemonitoring system will be implemented.
4. At the randomization visit, if the data obtained at home is confirmed in the telemonitoring system, the participant will be randomized. The Participants will visit the hospital every three months and they will be followed for 6 months.
5. When the physicians see the participants in person, the physicians will check CPAP adherence in CPAP telemonitoring system. Further, they will review the data from mHealth devices with the participants' smartphone without using mHealth telemonitoring system.
6. When the physicians see the participants in person, after checking these data, the physicians will instruct the participants to (1) optimize CPAP adherence, (2) measure BP, BW, and number of steps with the provided mHealth devices and send data to the mHealth telemonitoring system every day, and (3) reduce BW.
7. In months without the visit, the physician will check CPAP adherence once a month by the CPAP telemonitoring system. Further, physicians will review the data from mHealth devices via mHealth telemonitoring system. After reviewing these data, the physicians will give telephone feedback to the participants monthly. This feedback will provide the same guidance as when the participants see the physicians in person.
Interventions/Control_2 CPAP-telemonitoring Group
1. At the baseline visit, mobile health (mHealth) devices, namely the electrical weight scale, sphygmomanometer and pedometer will be provided to a participant. Attending physician will ask each participant to measure his or her weight, blood pressure and the number of steps on daily basis at home for self-monitoring. Further, the participant will be instructed to transmit the data to the mHealth telemonitoring system using their own smartphone and a dedicated mobile application. The Participant can confirm the obtained data anytime with his or her own smartphone.
2. The time interval of the visits will be extended from 1 or 2 to 3 months.
3. CPAP telemonitoring system will be implemented.
4. At the randomization visit, if the data obtained at home is confirmed in the telemonitoring system, the participant will be randomized. The Participants will visit the hospital every three months and they will be followed for 6 months.
5. When the physicians see the participants in person, the physicians will check CPAP adherence in CPAP telemonitoring system. Further, they will review the data from mHealth devices with the participants' smartphone without using mHealth telemonitoring system.
6. When the physicians see the participants in person, after checking these data, the physicians will instruct the participants to (1) optimize CPAP adherence, (2) measure BP, BW, and number of steps with the provided mHealth devices and send data to the mHealth telemonitoring system every day, and (3) reduce BW.
7. In months without the visit, the physician will check CPAP adherence once a month by the CPAP telemonitoring system. However, the physicians will not be allowed to review the data from mHealth devices remotely. After reviewing CPAP adherence data, the physicians will give telephone feedback to the participants just to optimize CPAP adherence. The physicians will not discuss weight reduction unless strongly requested by the participants.
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 or equal to 25 kg/m2
2. Apnea hypopnea index is more than or equal to 20/h by polysomnography or Respiratory event index is more than equal to 40/h by a portable monitoring device at OSA diagnosis
3. Visiting the clinic/hospital every month or every two months for the management of CPAP treatment based on the government health insurance rule.
4. The attending physician can confirm the patient's CPAP adherence at the study enrollment.
5. Patients owning a smartphone or tablet with Bluetooth function.
6. CPAP was implemented more than or equal to 1 month previously.
Key exclusion criteria 1.Secondary obesity (Obesity because of medication and endocrine disorder)
2.Impaired cognition
3.Chronic diseases affecting body weight (e.g. active malignancy and collagen diseases)
4.Dialysis
5.Body weight is more than or equal to 135kg (The Weight scale provided in this study cannot measure precisely for these patients.)
6.Attending physician recognize that exercise therapy cannot be recommended (BP >180/100, unstable angina, heart failure, respiratory failure, diabetes with renal failure, stroke and joint pain etc)
7. Hospitalization is scheduled during the study period
8. New nutritional or exercise therapy is scheduled during the study period for different purposes from that of the present study
9. The patient who has to see the attending physician every month or every two months for other reasons than CPAP management
10 Telemedicine intervention has already been 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 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038313
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038313
Number of participants that the trial has enrolled 168
Results The participants were invited from November 2018 to December 2019. The follow-up has been completed in August 2020. One hundred sixty-eight participants were evenly randomized to either of two groups.
The percentage of participants who achieved the primary outcome was significantly higher in the Multimodal-telemonitoring (MM-TM) group than CPAP-telemonitoring (CPAP-TM) group (39.3% vs. 25.0%, p=0.047)
Results date posted
2021 Year 09 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Body mass index at the baseline visit was 31.8(4.7) and 31.6 (5.1) kg/m2 in CPAP-TM and MM-TM group, respectively.
Participant flow The participant flow has been taken place as planned.
Adverse events Five participants were admitted to the hospitals because of pancreatitis, COVID-19, endometriosis, otitis media, and prostate cancer, respectively.
Outcome measures In regard to self-monitoring adherence, MM-TM group showed significantly better self-monitoring adherence of body weight than CPAP-TM group. (76.3(23.6) vs. 67.0(30.0) %, p=0.03)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
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
2020 Year 08 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
2021 Year 09 Month 18 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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