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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Changes in BMI [Срок оценки: 12 months]
• Changes in fat free mass [Срок оценки: 12 months]

Вторичные конечные точки (5)

• The difference before and after the treatment of mid-sleep time [Срок оценки: 12 months]
• The difference before and after the treatment of BMR (REE) [Срок оценки: 12 months]
• The difference before and after the treatment of BMR (RQ) [Срок оценки: 12 months]
• The difference before and after the treatment of Participants' nutrition intake [Срок оценки: 12 months]
• The difference before and after the treatment of attention and memory task [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06738940 · 202402098DINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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