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Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure

Determination of face-to-face medical care intervals for Adaptive Servo Ventilation (ASV) therapy with remote monitoring system in patients with chronic heart failure - Determination of face-to-face medical care intervals for ASV therapy with remote monitoring system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034166
Enrollment
61
Registered
2018-09-18
Start date
2018-12-01
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

Chronic herart failure

Interventions

During six months, we review the usage data of ASV therapy (the rate of days of ASV usage with four or more hours per day, the average usage time, the average apnea hypopnea index (AHI) per month) mon

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We recruit outpatients having chronic heart failure (NYHA grade 2 or more) and receiving ASV therapy. Patients can be included regardless of the indication for ASV therapy as far as they have already received ASV therapy and monthly or bimonthly face-to-face medical cares for three or more months at the outpatient setting, under the coverage by the national insurance service in Japan. At the time of enrollment, the usage data of ASV therapy within the preceding 28 days are necessary. Any remote monitoring system and any supplier and provider of the system are acceptable as far as the system can monitor the usage data of ASV therapy and has started to work at the time of baseline (the start of study). Patients can be included only when there has been no change in medication for heart failure within the previous three months and no admission for heart failure within the previous six months.

Exclusion criteria

Exclusion criteria: Patients are excluded when 1) they have cognitive impairment, 2) they have any history of cerebrovascular disease with residual neurological disabilities, 3) they need to receive monthly or more frequent face-to-face medical cares for ASV management from the same physicians, 4) they have been already scheduled for hospitalization during the study periods, 5) they have been already scheduled for changing treatment for heart failure, 6) they need to receive monthly or more frequent face-to-face medical cares for other reasons than domiciliary oxygen therapy management from the same physicians, 7) they have any active malignant neoplasm, 8) they are receiving chronic hemodialysis, or 9) they are receiving domiciliary oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Change in treatment adherence for Adaptive Servo Ventilation (ASV) therapy

Countries

Japan

Contacts

Public ContactKimihiko Murase

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