Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2020-02-07
2023-04-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Use of CPAP device
CPAP 12 weeks
CPAP
Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks
Usual care
Usual care 12 weeks
No interventions assigned to this group
Interventions
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CPAP
Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
2. patients with moderate-severe OSA (AHI≥15/hr)
Exclusion Criteria
2. wrist tattoos
3. BMI≧40 kg/m2
4. Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
5. Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
6. chronic heart failure(including NYHA class 3 or more than NYHA class 3)
7. COPD(FEV1/FVC\<70)
8. Hyperthyroidism or Hypothyroidism
9. Primary Aldosteronism
10. Chronic Kidney Disease(eGFR\<30)
11. Acromegaly and Parkinson's disease)
12. Psychosis(Schizophrenia, bipolar disorder and depression)
13. Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis)
14. Cancer(in last 5 years)
15. Have been diagnosed with obstructive sleep apnea
16. other sleep disorder(Narcolepsy, insomnia and RBD)
17. Use anti-inflammatory drugs(in last 2 weeks)
18. Illiterate
19. shift worker
20. has been Spinal Surgery and move difficult
21. professional driver has severe drowsiness
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pei-Lin Lee, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine
Locations
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Center of sleep disorders, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Liu PK, Ting N, Chiu HC, Lin YC, Liu YT, Ku BW, Lee PL. Validation of photoplethysmography- and acceleration-based sleep staging in a community sample: comparison with polysomnography and Actiwatch. J Clin Sleep Med. 2023 Oct 1;19(10):1797-1810. doi: 10.5664/jcsm.10690.
Other Identifiers
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201802034RIPD
Identifier Type: -
Identifier Source: org_study_id
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