Obstructive Sleep ApneaMSLS-LTNCT06738940
Long-term CPAP Effect with Obstructive Sleep Apnea: a Telemedicine-based
A study testing CPAP in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
we hypothesize that long-term CPAP could results in increase weight and muscle composite by changing intake content and hormone and the effect was influenced by presence of CVD, social jet lag, and CPAP compliance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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:≧20 year-old
- patients with moderate-severe OSA (AHI≥15/hr)
Who cannot join
- skin allergy
- wrist tattoos
- BMI≧40 kg/m2
- Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
- Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
- chronic heart failure(including NYHA class 3 or more than NYHA class 3)
Show all 21Show fewer
- COPD(FEV1/FVC<70)
- Hyperthyroidism or Hypothyroidism
- Primary Aldosteronism
- Chronic Kidney Disease(eGFR<30)
- Acromegaly and Parkinson's disease)
- Psychosis(Schizophrenia, bipolar disorder and depression)
- Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis)
- Cancer(in last 5 years)
- Have been diagnosed with obstructive sleep apnea
- other sleep disorder(Narcolepsy, insomnia and RBD)
- Use anti-inflammatory drugs(in last 2 weeks)
- Illiterate
- shift worker
- has been Spinal Surgery and move difficult
- professional driver has severe drowsiness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term CPAP Effect on Social Jet Lag, Intake, Muscular Lipid, Hormone, and Cognition in Patients with Obstructive Sleep Apnea: a Telemedicine-based, Multi-center, Randomized Controlled Trial
we hypothesize that long-term CPAP could results in increase weight and muscle composite by changing intake content and hormone and the effect was influenced by presence of CVD, social jet lag, and CPAP compliance. The project aims to conduct a telemedicine-based, multicenter, RCTs to compare the effect of 48-week CPAP and usual care on social jet lag, muscular fat, hormone, and attention and memory in 100 participants with moderate-severe OSA.
Read the detailed description
After the participants enter the trial, participants underwent two-night home PSG to confirm the diagnosis of OSA. Once AHI ³15/h is confirmed, participants undertake baseline evaluation within two weeks which included standard questionnaire, eating behavior, 3-day photograph-based intake recording, and 7-day sleep log, 24-hr ambulatory blood pressure, 7-day Actiwatch and Actigraph, 2-morning attention and memory task at home environment. The BMR, BC, Proton Magnetic Resonance Spectroscopy (1H-MRS), and blood sampling are conducted in the morning when patients was fasting at hospital.
Once participants complete the baseline evaluation, they are randomly allocated to the usual care or auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks. The randomization is generated by the staff of the Department of Biostatistics independent of subject enrolment. A block-randomized assignment with a block size of four is used. Consecutive patients are assigned to the allocation according to the randomization schedule by the study nurse.
After randomization, participants had virtual visits at 4th, 12th, 24th, and 48th week and are evaluated with the same measurements as pre-randomization after complete the trial.
Once the patients complete the trial, they receive the standard treatment of OSA and are followed every 24 to 48 weeks for five years.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP
- Keywords
- Body composition, Continuous positive airway pressure, Obstructive sleep apnea, social jet lag, cognition, muscular lipid
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Use of CPAP device | Experimental | CPAP 48 weeks Receives: Device: CPAP |
| Usual care | No intervention | Usual care 48 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BMI
By comparing the BMI of the CPAP group and the usual care group, observe the effect of CPAP on BMI.
Measured: 12 months
Changes in fat free mass
By comparing the fat free mass of the CPAP group and the usual care group, observe the effect of CPAP on fat free mass. Fat free mass was measured via bioelectrical impedance analysis (X-SCAN PLUS II, Jawon Medical Co., Ltd., Korea).
Measured: 12 months
Secondary outcomes (5)
The difference before and after the treatment of mid-sleep time
Evaluate mid-sleep time using the Actiwatch (Spectrum Plus, Philips Respironics, USA) and compare the differences between the CPAP group and the Usual Care group.
Measured: 12 months
The difference before and after the treatment of BMR (REE)
The difference in BMR(Basal metabolic rate) between the CPAP group and the usual care group. The comparison item is REE(Resting Energy Expenditure) (kcal/day)
Measured: 12 months
The difference before and after the treatment of BMR (RQ)
The difference in BMR(Basal metabolic rate) between the CPAP group and the usual care group. The comparison item is RQ(Respiratory Quotient) (kcal/day). The calculation method for RQ is to divide the amount of carbon dioxide (CO2) exhaled during BMR by the amount of oxygen (O2) consumed.
Measured: 12 months
The difference before and after the treatment of Participants' nutrition intake
Energy intake was recorded via food diaries and photographs of intake for 3 days. Compare the differences between the CPAP group and the usual care group.
Measured: 12 months
The difference before and after the treatment of attention and memory task
attention and memory task from E-Prime 3.0 software (Psychology Software Tools, Pittsburgh, PA, USA). Compare the differences between the CPAP group and the usual care group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2027 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Pei-Lin Lee, M.D., PhD, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738940
- Sponsor's protocol ID
- 202402098DINC
- Acronym
- MSLS-LT
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term CPAP Effect on Social Jet Lag, Intake, Muscular Lipid, Hormone, and Cognition in Patients with Obstructive Sleep Apnea: a Telemedicine-based, Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06738940
- Acronym / sponsor ID
- MSLS-LT / 202402098DINC
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Body composition, Continuous positive airway pressure, Obstructive sleep apnea, social jet lag, cognition, muscular lipid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Dec 2024 (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.
we hypothesize that long-term CPAP could results in increase weight and muscle composite by changing intake content and hormone and the effect was influenced by presence of CVD, social jet lag, and CPAP compliance. The project aims to conduct a telemedicine-based, multicenter, RCTs to compare the effect of 48-week CPAP and usual care on social jet lag, muscular fat, hormone, and attention and memory in 100 participants with moderate-severe OSA.
Detailed description
After the participants enter the trial, participants underwent two-night home PSG to confirm the diagnosis of OSA. Once AHI ³15/h is confirmed, participants undertake baseline evaluation within two weeks which included standard questionnaire, eating behavior, 3-day photograph-based intake recording, and 7-day sleep log, 24-hr ambulatory blood pressure, 7-day Actiwatch and Actigraph, 2-morning attention and memory task at home environment. The BMR, BC, Proton Magnetic Resonance Spectroscopy (1H-MRS), and blood sampling are conducted in the morning when patients was fasting at hospital.
Once participants complete the baseline evaluation, they are randomly allocated to the usual care or auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks. The randomization is generated by the staff of the Department of Biostatistics independent of subject enrolment. A block-randomized assignment with a block size of four is used. Consecutive patients are assigned to the allocation according to the randomization schedule by the study nurse.
After randomization, participants had virtual visits at 4th, 12th, 24th, and 48th week and are evaluated with the same measurements as pre-randomization after complete the trial.
Once the patients complete the trial, they receive the standard treatment of OSA and are followed every 24 to 48 weeks for five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of CPAP device | Experimental | Device: CPAPCPAP 48 weeks |
| Usual care | No intervention | –Usual care 48 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age:≧20 year-old
- patients with moderate-severe OSA (AHI≥15/hr)
Key exclusion criteria (21 listed)
- skin allergy
- wrist tattoos
- BMI≧40 kg/m2
- Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
- Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
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 |
|---|---|---|
| CPAPAuto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks | Device | Use of CPAP device |
Primary outcome
Changes in BMI
Time frame: 12 months
By comparing the BMI of the CPAP group and the usual care group, observe the effect of CPAP on BMI.
Changes in fat free mass
Time frame: 12 months
By comparing the fat free mass of the CPAP group and the usual care group, observe the effect of CPAP on fat free mass. Fat free mass was measured via bioelectrical impedance analysis (X-SCAN PLUS II, Jawon Medical Co., Ltd., Korea).
5 secondary outcomes
The difference before and after the treatment of mid-sleep time
Time frame: 12 months
The difference before and after the treatment of BMR (REE)
Time frame: 12 months
The difference before and after the treatment of BMR (RQ)
Time frame: 12 months
The difference before and after the treatment of Participants' nutrition intake
Time frame: 12 months
The difference before and after the treatment of attention and memory task
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- 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.
Pei-Lin Lee, M.D., PhD principal investigator
Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital 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 2 inclusion and 21 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Lin Lee, M.D., PhD (+886-223562755, sleep.chronobiology.pl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BMI (time frame: 12 months). The study lists 2 primary outcomes in all. 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 18 Dec 2024.