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| Name | Class |
|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | OTHER |
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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.
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 (AirSenseâ„¢ 10 Autosetâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of CPAP device | Experimental | CPAP 48 weeks |
|
| Usual care | No Intervention | Usual care 48 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Auto-CPAP treatment (AirSenseâ„¢ 10 Autosetâ„¢, ResMed Inc., Australia) for 48 weeks |
|
| 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 |
| 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) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Lin Lee, M.D., PhD | Contact | +886-223562755 | sleep.chronobiology.pl@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Lin Lee, M.D., PhD | Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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 |
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |