Obstructive Sleep ApneaT2DMNCT06760715
An Interactive Mobile Care on Self-management Among T2DM with OSA
A study testing an interactive m-health self-management in people with Obstructive Sleep Apnea and Type 2 Diabetes Mellitus (T2DM), run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- an interactive m-health self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 20 years with a physician-confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM)
- BMI greater than 24 kg/m2, or waist circumference (WC) greater than 90cm for men or greater than 80 cm for women
- AHI as evaluated by a home portable sleep monitor at > 5 times/hour and diagnosed with sleep apnea by a specialist in sleep apnea
- agreeing to participate in this 6-month study .current digital technology product users.
Who cannot join
- presence of major diseases such as cancer , renal failure or severe depression
- presence of cardiopulmonary diseases not suitable for physical activities
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Primary Healthcare Centers and Diabetes Care Network Clinics
Miaoli, 351
CHI CHUN physician, MEDICAL SCHOOL, 011-886-37664486, hsieh.yu88@gmail.com
About this study
Official title: Constructing an Interactive Mobile Health Cloud Platform of Care Model on Self-management Among the Community-based Type 2 Diabetes Mellitus Patients with Sleep Obstructive Apnea: a Randomized Clinical Trial
The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention.
Read the detailed description
Obstructive Sleep Apnea (OSA) is a common sleep disorder. It is estimated that nearly 1 billion adults are affected by OSA in worldwide. It is about 36-60% of Type 2 Diabetes Mellitus (T2DM) patients with OSA. Studies have shown that obesity is an independent risk factor for both OSA and T2DM, and the prevalence of obesity among adults in Taiwan has reached 45.4%. As a result, the incidence of T2DM has also increased annually and has become younger. For this reason, the OSA derived from it should not be underestimated. A three-year with longitudinal study will be conducted. In the first year, a cross-sectional study design is employed. Convenience sampling is used and 485 overweight community-based participants who will recruit from four diabetes co-care clinics in North and Central Taiwan. The Epworth Sleep Scale, Pittsburgh's Sleep Quality Index, Taiwanese depression Scale, Health Promotion Lifestyle Scale, and the home portable sleep monitor will be used for data collection. The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention. All data will be collected at baseline, 3, and 6 months after intervention. Generalized estimating equation is employed to analyze the effectiveness of the intervention. Hopefully, the findings of this study will serve as a reference for the health care providers and will help construct a model of care for people with overweight and obese T2DM with OSA in the community.
- Being tested
- an interactive m-health self-management, In the control group
- Keywords
- Obstructive Sleep Apnea, Type 2 Diabetes Mellitus, m-health self-management, home portable sleep monitor
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an interactive m-health self-managementBehavioural
Description: The experimental group will undergo a lifestyle intervention based on the Transtheoretical Model (TTM), utilizing the MOSAC cloud platform. This intervention focuses on self-management to facilitate behavior changes aimed at weight loss and improving Obstructive Sleep Apnea (OSA) of T2DM patients. Key components include self-monitoring, tracking, real-time feedback, and customized weight loss plans, all enhanced by gamification features. The intervention emphasizes a healthy approach to weight loss, promoting a balanced diet, moderate calorie reduction, and increased physical activity, such as step counts. Each stage of the intervention outlines specific objectives, processes, and measures for achieving behavioral change and supporting healthy weight loss.
In the control groupBehavioural
Description: In the control group, standard medical care will continue to be provided along with written educational pamphlets on weight loss and sleep hygiene. The interactive m-health cloud platform will not be offered. However, the results of the three questionnaires administered to each participant will be individually explained, and any questions will be addressed immediately. After the activity concludes, participants may choose to receive the same intervention as the experimental group, if they wish.
| Study group | Role | What they receive |
|---|---|---|
| m-Health My OSA Coach | Experimental | Not described Receives: Behavioral: an interactive m-health self-management |
| control group | Placebo comparator | Not described Receives: Behavioral: In the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.
AHI is represented by the number of apnea and hypopnea events per hour of sleep. In this study, OSA was defined as the value of AHI greater than 5 events/ hr. In addition, participants were determined as having mild, moderate, and severe OSA if they had AHI 5-14 events /hr, 15-30 events /hr, and > 30 events /hr, respectively (Jonas et al., 2017).
Measured: 24weeks
Secondary outcomes (1)
The secondary outcome measures include changes in OSA-related factors such as HbA1c, BMI, sleep quality, daytime sleepiness, depression, and health-promoting lifestyle.
The secondary outcome measures include changes in OSA-related factors including (1) HbA1c in percentage (%), (2)weight in kilogram, (3)height in meters, (4) weight and height will be combined to report BMI( kg/m^2), (5) Pittsburgh's Sleep Quality Index was used to examine sleep quality. The total score ranges from 0 to 21, high scores indicated a poor sleep, (6) Epworth Sleep Scale was used to assess the severity of participants' sleepiness while performing daily activities, the total score ranges from 0 to 24 points, higher scores indicated a higher chance of dozing, (7)Taiwanese Depression Questionnaire was used to assess depression, a total score ranged from 0 to 54 points, higher scores indicated a sever level of depression, (8) Health-Promoting Lifestyle Profile was used to examine participants' health-promoting lifestyle behavior, the total score ranges from 24 to 96 points, higher scores on individual indicated a higher level of engagement in health-promoting behaviors.
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsu Hsiu-Chin, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760715
- Sponsor's protocol ID
- IRB No.: 202202281B0
- Acronym
- T2DM
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructing an Interactive Mobile Health Cloud Platform of Care Model on Self-management Among the Community-based Type 2 Diabetes Mellitus Patients with Sleep Obstructive Apnea: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06760715
- Acronym / sponsor ID
- T2DM / IRB No.: 202202281B0
- Keywords
- Obstructive Sleep Apnea, Type 2 Diabetes Mellitus, m-health self-management, home portable sleep monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention.
Detailed description
Obstructive Sleep Apnea (OSA) is a common sleep disorder. It is estimated that nearly 1 billion adults are affected by OSA in worldwide. It is about 36-60% of Type 2 Diabetes Mellitus (T2DM) patients with OSA. Studies have shown that obesity is an independent risk factor for both OSA and T2DM, and the prevalence of obesity among adults in Taiwan has reached 45.4%. As a result, the incidence of T2DM has also increased annually and has become younger. For this reason, the OSA derived from it should not be underestimated. A three-year with longitudinal study will be conducted. In the first year, a cross-sectional study design is employed. Convenience sampling is used and 485 overweight community-based participants who will recruit from four diabetes co-care clinics in North and Central Taiwan. The Epworth Sleep Scale, Pittsburgh's Sleep Quality Index, Taiwanese depression Scale, Health Promotion Lifestyle Scale, and the home portable sleep monitor will be used for data collection. The aim of the second and third year is to construct the "Care model of improving for overweight or obese T2DM with OSA" based on the transtheoretical model, and to import an interactive m-health self-management (m-Health My OSA Coach; MOSAC)" cloud platform to examine the effectiveness of OSA in T2DM participants. A randomized controlled trial study design will be adopted. Eligible OSA participants who have been screened for OSA following the first stage will be invited to the second stage. The participants will be randomly divided into either experimental or control group with 1:1 ratio. The total duration of intervention program is 6 months. Only the experimental group receives the MOSAC intervention. All data will be collected at baseline, 3, and 6 months after intervention. Generalized estimating equation is employed to analyze the effectiveness of the intervention. Hopefully, the findings of this study will serve as a reference for the health care providers and will help construct a model of care for people with overweight and obese T2DM with OSA in the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-Health My OSA Coach | Experimental | Behavioral: an interactive m-health self-management |
| control group | Placebo comparator | Behavioral: In the control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 20 years with a physician-confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM)
- BMI greater than 24 kg/m2, or waist circumference (WC) greater than 90cm for men or greater than 80 cm for women
- AHI as evaluated by a home portable sleep monitor at > 5 times/hour and diagnosed with sleep apnea by a specialist in sleep apnea
- agreeing to participate in this 6-month study .current digital technology product users.
Key exclusion criteria (2 listed)
- presence of major diseases such as cancer , renal failure or severe depression
- presence of cardiopulmonary diseases not suitable for physical activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an interactive m-health self-managementDescription: The experimental group will undergo a lifestyle intervention based on the Transtheoretical Model (TTM), utilizing the MOSAC cloud platform. This intervention focuses on self-management to facilitate behavior changes aimed at weight loss and improving Obstructive Sleep Apnea (OSA) of T2DM patients. Key components include self-monitoring, tracking, real-time feedback, and customized weight loss plans, all enhanced by gamification features. The intervention emphasizes a healthy approach to weight loss, promoting a balanced diet, moderate calorie reduction, and increased physical activity, such as step counts. Each stage of the intervention outlines specific objectives, processes, and measures for achieving behavioral change and supporting healthy weight loss. | Behavioural | m-Health My OSA Coach |
| In the control groupDescription: In the control group, standard medical care will continue to be provided along with written educational pamphlets on weight loss and sleep hygiene. The interactive m-health cloud platform will not be offered. However, the results of the three questionnaires administered to each participant will be individually explained, and any questions will be addressed immediately. After the activity concludes, participants may choose to receive the same intervention as the experimental group, if they wish. | Behavioural | control group |
Primary outcome
The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor.
Time frame: 24weeks
AHI is represented by the number of apnea and hypopnea events per hour of sleep. In this study, OSA was defined as the value of AHI greater than 5 events/ hr. In addition, participants were determined as having mild, moderate, and severe OSA if they had AHI 5-14 events /hr, 15-30 events /hr, and > 30 events /hr, respectively (Jonas et al., 2017).
1 secondary outcome
The secondary outcome measures include changes in OSA-related factors such as HbA1c, BMI, sleep quality, daytime sleepiness, depression, and health-promoting lifestyle.
Time frame: 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an interactive m-health self-management in people with Obstructive Sleep Apnea and Type 2 Diabetes Mellitus (T2DM), run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHI CHUN physician, master (011-886-37664486, hsieh.yu88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the change in AHI (times/hour) detected by a home-use portable sleep monitor. (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.