UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033607
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

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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 or person

Institute

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

Institute

Department

Personal name



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 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.

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

2022 Year 02 Month 25 Day



Link to view the page

Value
https://center6.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