Telemonitoring in CPAP Treatment

Sleep Apnea Clinical Trial

— TeleCPAP  

Official title:

Telemonitoring in CPAP Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509247
• Other study ID #: T200/2013
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: July 23, 2015
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial Summary

Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

Description:

Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

This study was part of our regular testing and quality assurance procedure when developing and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable changes in treatment protocol we have to test whether it is feasible and cost-effective to change the protocol. The data was retrospectively collected from hospital records and nurses' notes (nursing time). According to instructions of our hospital, the Ethics Committee approval is not required. The approval of the hospital (Head of the Division of Medicine) for testing the wireless telemonitoring system of CPAP treatment was applied and received (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained from those patients allocated to the telemonitoring group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consecutive adult patients commencing CPAP therapy for OSA

Exclusion Criteria:

• Patient not able to co-operate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea

Intervention

Device:
• Telemonitoring
Wireless telemonitoring

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nursing time	Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records	3 months	No
Secondary	CPAP adherence measured with in-built clock counter		1 year	No