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Non-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

Non-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 - Telemonitoring study of CPAP for SAS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023319
Enrollment
60
Registered
2016-07-25
Start date
2016-07-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patients who are newly diagnosed as sleep apnea syndrome and start continuous positive airway pressure treatment

Interventions

ICT Group 60 samples. For ICT group, use of CPAP is monitored by cloud server on the 3rd,7th and 14th day after the start of therapy as well as after one and two months. Communication by telephone an

Sponsors

Inoue Hospital
Lead Sponsor
Nagasaki University Yamax
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Outpatient only 2. Diagnosed as obstructive sleep apnea syndrome (OSAS) and has apnea-hypopnea Index (AHI) higher than 20 by polysomnography (PSG) 3. Direct contact is possible by telephone or e-mail 4. Patient who agreed to participate to this clinical study by written informed concent by his/her own free will after being well informed and understanding about this study.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Average time of CPAP use on days used 3 months after CPAP introduction.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHiroyuki Yoshimine

Inoue Hospital Internal Medicine

yoshy@shunkaikai.jp095-844-1281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026