Telemonitoring of CPAP Therapy in Sleep Apnea Patients

University of Turku

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Telemonitoring via wireless internet-based system

Study type: Interventional

Funder types: Other

Identifiers

NCT04868422

K53 (Other Identifier)

T83/2012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with diagnosed obstructive sleep apnea

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Telemonitoring

Experimental group

Description:

After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device

Treatment:

Device: Telemonitoring via wireless internet-based system

Usual care

No Intervention group

Description:

Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring