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NCT Number: NCT06738940

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location contact

Pei-Lin Lee

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CPAP

Device

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

Primary outcomes

  1. Changes in BMI

    Time frame: 12 months

    By comparing the BMI of the CPAP group and the usual care group, observe the effect of CPAP on BMI.

  2. Changes in fat free mass

    Time frame: 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 outcomes

  1. The difference before and after the treatment of mid-sleep time

    Time frame: 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.

  2. The difference before and after the treatment of BMR (REE)

    Time frame: 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)

  3. The difference before and after the treatment of BMR (RQ)

    Time frame: 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.

  4. The difference before and after the treatment of Participants' nutrition intake

    Time frame: 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.

  5. The difference before and after the treatment of attention and memory task

    Time frame: 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.

Other outcomes

  1. 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.

    Time frame: 12 months

    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.

  2. The difference before and after the treatment of Biochemistry, hormone and cytokine(blood test)

    Time frame: 12 months

    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.

  3. The difference before and after the treatment of 24h blood pressure

    Time frame: 12 months

    The difference in 24-h systolic, diastolic(mmHg), and mean BP(mmHg) between the CPAP group and the usual care group.

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Lin Lee, M.D., PhD

CONTACT

[email protected]

+886-223562755

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Registry information

Official study 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

Acronym: MSLS-LT

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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