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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Lin Lee, M.D., PhD; Phone Number: +886-223562755; Email: sleep.chronobiology.pl@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
    • Contact: Pei-Lin Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of CPAP device; CPAP 48 weeks	Device: CPAP; Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 48 weeks
No Intervention: Usual care; Usual care 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in BMI	By comparing the BMI of the CPAP group and the usual care group, observe the effect of CPAP on BMI.	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	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.	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After wearing the Actiwatch(Spectrum Plus, Philips Respironics, USA) for 7 days and recording the sleep log for 7 days, the bedtime and wake-up time recorded by the device will be compared with the bedtime and wake-up time reported by the patient to identify any discrepancies. This will be used to compare the pre- and post-treatment differences between the usual care group and the CPAP group.	12 months
The difference before and after the treatment of Biochemistry, hormone and cytokine(blood test)	Through CPAP treatment, blood test results for cortisol, lipid profile (T-CHO, TG, LDL, HDL), hsCRP, glucose, and insulin are expected to show differences in levels compared to pre-treatment values. This will be used to compare the usual care group and the CPAP group, in order to demonstrate the effectiveness of CPAP treatment.	12 months
The difference before and after the treatment of 24h blood pressure	The difference in 24-h systolic, diastolic(mmHg), and mean BP(mmHg) between the CPAP group and the usual care group.	12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Pei-Lin Lee, M.D., PhD, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; cognition; Body composition; Continuous positive airway pressure; social jet lag; muscular lipid
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 202402098DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No