on-randomized, single-center study for efficacy and safety of telemonitoring in the continuous positive airway pressure treatment for patient with newly diagnosed sleep apnea syndrome
- Conditions
- The patients who are newly diagnosed as sleep apnea syndrome and start continuous positive airway pressure treatment
- Registration Number
- JPRN-UMIN000023319
- Lead Sponsor
- Inoue Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Not provided
Patients who meet one of the following criteria are excluded. 1. Patients with predominant central sleep apnea (CSA) 2. Patients with severe heart failure 3. Patient with severe respiratory failure 4. Patient with dementia 5. Patients with severe sleep disorder except SAS 6. Patients who some significant disease which influences CPAP therapy 7. Patients with claustrophobia 8. Patients who has past history of CPAP therapy. 9. Patients who want to be treated with oral appliance 10. Patients with significant nasal obstruction. 11. Occupational bus, truck, and taxi drivers who are screened by regular check-up, diagnosed as SAS, and introduced CPAP treatment. 12. Patient who sleeps without intending 13. Patients who cannot be contacted by telephone or e-mail regularly 14. Patients who participated in the other clinical study in last four months 15. Patients who are regularly visit our hospital with interval shorter than 3 months 16. Patients who are assessed as inadequate as the object of this clinical study by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average time of CPAP use on days used 3 months after CPAP introduction.
- Secondary Outcome Measures
Name Time Method 1. Drop-out rate 2. The percentage of CPAP usage less than 4 hours 3. Average CPAP use on whole days 4. Residual AHI 5. Mask leak 6. Japanese Excessive sleepiness score 7. SF-36 8. Reason that stopped therapy 9.Travelling time to the hospital for patient 10. Time to follow up and care patient for doctors and co-medicals. 11. Time for care of patient for home care provider