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Clinical Trials/NCT04868422
NCT04868422
Completed
Not Applicable

Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients

University of Turku1 site in 1 country111 target enrollmentAugust 14, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
University of Turku
Enrollment
111
Locations
1
Primary Endpoint
Nursing time
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2012
End Date
March 12, 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tarja Saaresranta

Investigator

University of Turku

Eligibility Criteria

Inclusion Criteria

  • Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria

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

Outcomes

Primary Outcomes

Nursing time

Time Frame: One year after the baseline

Nursing 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 Outcomes

  • Hours of CPAP use(One year after baseline)

Study Sites (1)

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