NCT06738940

Long-term CPAP Effect with Obstructive Sleep Apnea: a Telemedicine-based

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	CPAP	Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2027-07-31
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: Taiwan