Unique ID issued by UMIN | UMIN000033607 |
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Receipt number | 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 | 2022/02/25 23:11:57 |
The effects of telemedicine intervention on weight loss in obese sleep apnea patients with CPAP use
Telemedicine for Obese Sleep Apnea Patients study (TMOSAP)study
The effects of telemedicine intervention on weight loss in obese sleep apnea patients with CPAP use
Telemedicine for Obese Sleep Apnea Patients study (TMOSAP)study
Japan |
Obesity
Obstructive Sleep Apnea
Medicine in general | Cardiology | Pneumology |
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Confirmatory
Others
Not applicable
The number of participants who achieved 3% weight reduction within the observational period.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Educational,Counseling,Training
Behavior,custom |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
140
1st name | Kazuo |
Middle name | |
Last name | Chin |
Graduate School of Medicine, Kyoto University
Respiratory Care and Sleep Contorol Medicine
6068507
54 Kawaharacho Sakyo Kyoto Japan
(+81)757513852
enkaku@kuhp.kyoto-u.ac.jp
1st name | Murase |
Middle name | |
Last name | Kimihiko |
Graduate School of Medicine, Kyoto University
Respiratory Care and Sleep Contorol Medicine
6068507
54 Kawaharacho Sakyo Kyoto Japan
(+81)757513852
enkaku@kuhp.kyoto-u.ac.jp
Respiratory Care and Sleep Contorol Medicine, Graduate School of Medicine, Kyoto University
Health , Labour and Welfare Sciences Research Grants, Research on Region Medical (H30-iryou-ippan-009)
Japanese Governmental office
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
Kyoto University Hospital Ethics Committee
54 Kawaharacho Sakyo Kyoto Japan
81-75-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
2018 | Year | 10 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038313
Unpublished
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038313
168
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)
2021 | Year | 09 | Month | 18 | Day |
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.
The number of subjects enrolled exceeded the planned number due to a large number of registrations in a short period of time during the final phase of the enrolment period.
Five participants were admitted to the hospitals because of pancreatitis, COVID-19, endometriosis, otitis media, and prostate cancer, respectively.
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)
Completed
2018 | Year | 08 | Month | 01 | Day |
2018 | Year | 10 | Month | 22 | Day |
2018 | Year | 11 | Month | 01 | Day |
2020 | Year | 08 | Month | 31 | Day |
2018 | Year | 08 | Month | 02 | Day |
2022 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038313
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