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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks
Center of sleep disorders, National Taiwan University Hospital
Taipei, Taiwan
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)
Time frame: 12 weeks
The difference before and after the treatment of BC(total fat mass and fat free mass)
Compare the total fat mass and fat free mass between the usual care group and the CPAP group to demonstrate the effectiveness before and after treatment. The units for total fat mass and fat free mass are both in kg.
Time frame: 12 weeks
The difference before and after the treatment of energy intake and percentage of nutrients
The difference before and after treatment is represented by comparing the calorie intake from the three-day food diaries between the usual care group and the CPAP group. The evaluation unit is total calories (% nutrition).
Time frame: 12 weeks
The difference before and after the treatment of eating behavior
Compare the eating behavior between the usual care group and the CPAP group to demonstrate the differences before and after treatment. Eating behavior includes cognitive restraint, uncontrolled eating, and emotional eating, which are assessed using the 18 items of the Three-Factor Eating Questionnaire(TFEQ).
Time frame: 12 weeks
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.
Time frame: 12 weeks
The difference before and after the treatment of sleep parameters
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The difference before and after treatment is represented by comparing sleep parameters (hours of sleep, TIB, sleep efficiency) between the usual care group and the CPAP group. The activity levels are measured using an Actiwatch (Spectrum Plus, Philips Respironics, USA).
Time frame: 12 weeks
The difference before and after the treatment of Physical Activity(PA)
Compare the difference between participants' self-reported International Physical Activity Questionnaire-Short Form(IPAQ-SF) questionnaire and the objectively measured physical activity from the Actiwatch to demonstrate the effectiveness of CPAP treatment. The IPAQ-SF primarily analyzes total physical activity (MET time/week) and the percentage of vigorous-intensity activity, while the Actiwatch analyzes the average activity count per minute measured by the device.
Time frame: 12 weeks