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Determination of face-to-face medical care intervals for continuous positive airway pressure therapy with remote monitoring system

Determination of face-to-face medical care intervals for continuous positive airway pressure therapy with remote monitoring system - Determination of face-to-face medical care intervals for CPAP therapy with remote monitoring system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023118
Enrollment
450
Registered
2016-07-11
Start date
2016-11-01
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

Sleep apnea syndrome

Interventions

Intervention 1: During six months, we review the usage data of CPAP therapy (the rate of days of CPAP usage with four or more hours per day and the average apnea hypopnea index (AHI) per month) monthl

Sponsors

Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We recruit outpatients having sleep apnea syndrome (SAS) diagnosed by polysomnography or unattended portable monitors and receiving CPAP therapy Patients can be included only when they have already received CPAP therapy and monthly or bimonthly face-to-face medical cares for three or more months at the outpatient setting and their SAS has been controlled at the monthly average AHI of 20 or less based on the remote monitoring or smartcard tracking data. At the time of enrollment, the usage data of CPAP therapy within the preceding three months through the remote monitoring or smartcard tracking system are necessary for randomization. Any remote monitoring system and any supplier and provider of the system are acceptable as far as the system can monitor the usage time of CPAP therapy per day and the average AHI per month and has started to work at the time of baseline (the start of study).

Exclusion criteria

Exclusion criteria: Patients are excluded when 1) they need to receive monthly or more frequent face-to-face medical cares for other reasons than CPAP therapy management from the same physicians, 2) they are receiving domiciliary oxygen therapy, 3) they have any active malignant neoplasm, 4) their cognitive functions are impaired enough to prevent them from completing the questionnaires or understanding the guidance through telemedicine or 5) they have been already scheduled for hospitalization during the study periods.

Design outcomes

Primary

MeasureTime frame
The rate of days of CPAP usage with four or more hours per day during six month (The change in this rate between before and after the intervention will be evaluated. >5% decline will be defined as the adherence deterioration, and the number of patients with the deterioration will be examined.)

Countries

Japan

Contacts

Public ContactKiminobu Tanizawa

Kyoto University, Graduate School of Medicine Department of Respiratory Care and Sleep Control Medicine

enkaku@kuhp.kyoto-u.ac.jp075-751-3852

Outcome results

None listed

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