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The Impact of Comparing Treatment Status with Other Patients on Adherence to CPAP Therapy (CPAP-League Trial)

The Impact of Comparing Treatment Status with Other Patients on Adherence to CPAP Therapy (CPAP-League Trial) - CPAP League Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058037
Enrollment
186
Registered
2025-06-25
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Sleep apnea

Interventions

When a patient who is a potential participant visits the outpatient clinic for continuation of CPAP therapy, their CPAP adherence in the previous month will be reviewed. If the patient background char

Sponsors

Kyoto university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. CPAP therapy has been initiated for SAS, diagnosed according to Japanese public health insurance criteria (apnea hypopnea index (AHI) >= 20/h by polysomnography, or respiratory event index (REI) is equal to or more than 40/h by portable monitoring device at the time of OSA diagnosis). 2. The patient is regularly attending outpatient visits to maintain CPAP therapy, in accordance with Japanese public health insurance requirements. 3. At least three months have passed since the introduction of the CPAP telemonitoring system.

Exclusion criteria

Exclusion criteria: A) Treatment adherence is already sufficiently good, with little need for further improvement. (Defined as a proportion of days with >4 hours of CPAP use of 90% or higher, and an average daily usage time >=7 hours over the past 1 month.) B) No CPAP usage at all during the past 1 month (for example, due to business trips, caring for family members, or other social reasons resulting in an inability to use CPAP, and for whom improvement in adherence through this intervention is not expected). C) Working night shifts twice or more a week. D) Patients with cognitive impairment

Design outcomes

Primary

MeasureTime frame
The primary outcome is the number of participants whose CPAP adherence improved, comparing before and after the intervention. CPAP adherence during the six months following the start of the intervention will be compared with adherence during the three months prior to obtaining consent. Improvement in adherence will be defined as meeting either of the following criteria: (1) The average daily usage time increases by 30 minutes or more, or (2) The average daily CPAP usage time increases, AND the proportion of days with CPAP usage of 4 hours or more per day increases by 10 percentage points or more.

Secondary

MeasureTime frame
In addition to the primary outcome, the following secondary outcomes were set: (1) Change in the proportion of days with CPAP usage of 4 hours or more per day, comparing the 3 months prior to obtaining consent and the 6 months following the intervention (2) Change in average daily CPAP usage time, comparing the 3 months prior to obtaining consent and the 6 months following the intervention (3) Change in the proportion of days with CPAP usage of 4 hours or more per day, comparing the month prior to obtaining consent and the 6 months following the intervention (4) Change in average daily CPAP usage time, comparing the month prior to obtaining consent and the 6 months following the intervention (5) Change in sleepiness, comparing the time of enrollment and 6 months after the intervention

Countries

Japan

Contacts

Public ContactKimihiko Murase

Graduate School of Medicine, Kyoto University Departement of Respiratory Medicine

kyodaisuimin@kuhp.kyoto-u.ac.jp0757513852

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026