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临床试验/NCT04252482
NCT04252482已完成不适用

Validation of Sleep Healthcare System

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
The difference before and after the treatment of BMR (REE)

研究概览

简要总结

The present project aims to that examine the interplay between sleep duration circadian phase, and metabolic regulation. The impact of CPAP therapy on metabolic regulation is assessed with a RCT. Patients were enrolled form referral to sleep clinic for suspect obstructive sleep apnea (OSA). Subjects with hypopnea index (AHI) >=15/h are randomly allocated to the usual care or Auto-PAP (APAP) therapy then reevaluated after 12th week. The CPAP effect are measured with the comparison of changes in outcomes between usual care and APAP therapy.

详细描述

Enrolled participants undertake pre-randomization evaluations. That included standard questionnaire, eating behavior, International Physical Activity Questionnaire (IPAQ)-short form, 3-day dietary intake, and 7-day sleep log, 24-hr ambulatory blood pressure, and 7-day Actiwatch. Within one week after completion, participants underwent repeated polysomnography (PSG) to confirm the diagnosis of OSA. The basal metabolic rate (BMR) and body composition (BC), and blood sampling are conducted in the morning next to overnight PSG and BMR.

Once the pre-randomization evaluation was completed and the AHI >=15/h was confirmed, participants are randomly allocated to the usual care or auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks. Participants had two follow-up visits at 4th and 12th week and were reevaluated with the same measurements as pre-randomization Enrolled participants are randomized into CPAP or usual care. 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. Investigators who assess outcome are blinded to the allocation assignment. Preset-dropout criteria: Defaulting clinic visits at 4th and 12-week, re-assessment, and clinical exacerbations requiring medical attention.

Participants starting CPAP are instructed to use the device for >=6hr/night. PAP compliance is assessed as the average usage hours per night which is objectively recorded on the devices with a built-in compliance meter. Compliance data are downloaded by medical staff at every clinic visit. The good compliance is defined as usage>= 4hr/night in 70% days of total period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >=20 year-old
  • patients with moderate-severe OSA (AHI≥15/hr)

排除标准

  • 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)
  • shift worker
  • has been Spinal Surgery and move difficult
  • professional driver has severe drowsiness

结局指标

主要结局

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

时间窗: 12 weeks

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)

次要结局

  • The difference before and after the treatment of BC(total fat mass and fat free mass)(12 weeks)
  • The difference before and after the treatment of energy intake and percentage of nutrients(12 weeks)
  • The difference before and after the treatment of eating behavior(12 weeks)
  • The difference before and after the treatment of 24h blood pressure(12 weeks)
  • The difference before and after the treatment of sleep parameters(12 weeks)
  • The difference before and after the treatment of Physical Activity(PA)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Validation of Sleep Healthcare System | 临床试验