Long-term CPAP Effect with Obstructive Sleep Apnea: a Telemedicine-based (MSLS-LT)

National Taiwan University

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT06738940

202402098DINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Use of CPAP device

Experimental group

Description:

CPAP 48 weeks

Treatment:

Device: CPAP

Usual care

No Intervention group

Description:

Usual care 48 weeks