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

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06738940
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in BMI	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	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).

Secondary Outcome Measures

Name	Time	Method
The difference before and after the treatment of mid-sleep time	12 months	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.
The difference before and after the treatment of BMR (REE)	12 months	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)
The difference before and after the treatment of BMR (RQ)	12 months	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.
The difference before and after the treatment of Participants' nutrition intake	12 months	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.
The difference before and after the treatment of attention and memory task	12 months	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan