Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868422
• Other study ID #: T83/2012
• Secondary ID: K53
• Status: Completed
• Phase: N/A
• Start date: August 14, 2012
• Est. completion date: March 12, 2015

Study information

• Verified date: April 2021
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 12, 2015
• Est. primary completion date: August 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Telemonitoring via wireless internet-based system

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual apnea-hypopnea index (AHI)	Maan AHI over 12 months according the CPAP-device	One year after baseline
Primary	Nursing time	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.	One year after the baseline
Secondary	Hours of CPAP use	Hours of CPAP use measured by the inbuilt counter of the CPAP device	One year after baseline