Clinical trial NCT06738940: Long-term CPAP Effect with Obstructive Sleep Apnea: a Telemedicine-based
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Body composition
Continuous positive airway pressure
Obstructive sleep apnea
social jet lag
cognition
muscular lipid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University Chung-Ho Memorial Hospital
First posted: 2024-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. age:≧20 year-old
2. patients with moderate-severe OSA (AHI≥15/hr)

Exclusion Criteria:

1. skin allergy
2. wrist tattoos
3. BMI≧40 kg/m2
4. Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
5. Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
6. chronic heart failure(including NYHA class 3 or more than NYHA class 3)
7. COPD(FEV1/FVC\<70)
8. Hyperthyroidism or Hypothyroidism
9. Primary Aldosteronism
10. Chronic Kidney Disease(eGFR\<30)
11. Acromegaly and Parkinson's disease)
12. Psychosis(Schizophrenia, bipolar disorder and depression)
13. Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis)
14. Cancer(in last 5 years)
15. Have been diagnosed with obstructive sleep apnea
16. other sleep disorder(Narcolepsy, insomnia and RBD)
17. Use anti-inflammatory drugs(in last 2 weeks)
18. Illiterate
19. shift worker
20. has been Spinal Surgery and move difficult
21. professional driver has severe drowsiness

Primary outcomes:
measure: Changes in BMI
timeFrame: 12 months
measure: Changes in fat free mass
timeFrame: 12 months
Secondary outcomes:
measure: The difference before and after the treatment of mid-sleep time
timeFrame: 12 months
measure: The difference before and after the treatment of BMR (REE)
timeFrame: 12 months
measure: The difference before and after the treatment of BMR (RQ)
timeFrame: 12 months
measure: The difference before and after the treatment of Participants' nutrition intake
timeFrame: 12 months
measure: The difference before and after the treatment of attention and memory task
timeFrame: 12 months
Other outcomes:
measure: Evaluate the difference between the usual care group and the CPAP group by comparing the activity levels measured by the Actiwatch and the sleeplog filled out by the patients.
timeFrame: 12 months
measure: The difference before and after the treatment of Biochemistry, hormone and cytokine(blood test)
timeFrame: 12 months
measure: The difference before and after the treatment of 24h blood pressure
timeFrame: 12 months
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine
name: Pei-Lin Lee, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: