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Randomized, sham-controlled, cross-over trial for effects of web-based telemedicine and health-professional aid on PAP adherence in OSA patients

Randomized, sham-controlled, cross-over trial for effects of web-based telemedicine and health-professional aid on PAP adherence in OSA patients - Study for judging the effects of active interventions on PAP therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013644
Enrollment
46
Registered
2014-04-05
Start date
2012-04-01
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

Patients with obstructive sleep apnea

Interventions

1) Web-based telemedicine followed by addition of active intervention by health professionals (protocol-1) 2) 2-months observation for each intervention 1) Combination of web-based telemedicine and

Sponsors

Comprehensive Medical Center of Sleep Disorders Tokyo Women's Medical University Aoyama Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients with moderate to severe OSA, who continue a stable PAP therapy for at least 2 months after its initiation

Exclusion criteria

Exclusion criteria: 1) Subjects who refused to participate in the study or those who were joining in other studies concurrently advanced in the Center. 2) Subjects who had no abnormal respiration during sleep. 3) Subjects with central sleep apneas. 4) Subjects with any pathological condition, including malignancy in any organ, severe heart failure, heart attack or stroke, renal failure requiring dialysis, or impaired cognitive function. 5) Subjects with mild-to-moderate OSA, to whom the PAP was not introduced. 6) Subjects who had the experience of previous treatment with either PAP or oral appliance. 7) Subjects who had much difficulty in optimal use of PAP device during the two months prior to entry into the study. 8) Subjects whose experience to use PAP was less than two months after initiating PAP therapy.

Design outcomes

Primary

MeasureTime frame
The additional effects of active interventions by health professionals appended to web-based telemedicine on PAP adherence during 6-months observation period

Secondary

MeasureTime frame
The withdrawal (negative) effects of active interventions by health professionals from web-based telemedicine monitoring on PAP adherence during 6-months observation period

Countries

Japan

Contacts

Public ContactKazuhiro Yamaguchi

Tokyo Women's Medical University Aoyama Hospital Comprehensive Medical Center of Sleep Disorder

yamaguc@sirius.ocn.ne.jp+81-3-5411-8111

Outcome results

None listed

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