Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Telemonitoring via wireless internet-based system

• Registration Number: NCT04868422
• Lead Sponsor: University of Turku

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.

Study Timeline

• Study Start: 2012-08-14
• Primary Completion: 2014-08-12
• Study Completion: 2015-03-12
• Status Verified: 2021-04
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-05-03
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Telemonitoring via wireless internet-based system	After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device

Primary Outcome Measures

Name	Time	Method
Nursing time	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 Outcome Measures

Name	Time	Method
Hours of CPAP use	One year after baseline	Hours of CPAP use measured by the inbuilt counter of the CPAP device

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland