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Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868422
Enrollment
111
Registered
2021-05-03
Start date
2012-08-14
Completion date
2015-03-12
Last updated
2021-05-03

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

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction

Brief summary

Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

Detailed description

Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was \>4 h/day, mask leak \<0.4 L/s, and AHI \<5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.

Interventions

DEVICETelemonitoring via wireless internet-based system

Sponsors

Turku University Hospital
CollaboratorOTHER_GOV
University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients with diagnosed obstructive sleep apnea

Exclusion criteria

* Not able to understand Finnish language * Unable to co-operate

Design outcomes

Primary

MeasureTime frameDescription
Nursing timeOne year after the baselineNursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group.

Secondary

MeasureTime frameDescription
Hours of CPAP useOne year after baselineHours of CPAP use measured by the inbuilt counter of the CPAP device

Other

MeasureTime frameDescription
Residual apnea-hypopnea index (AHI)One year after baselineMaan AHI over 12 months according the CPAP-device

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026