Back to resultsTelemonitoring in CPAP Treatment (TeleCPAP)
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, CPAP, telemonitoring, telecare
Eligibility Criteria
Inclusion Criteria:
- Consecutive adult patients commencing CPAP therapy for OSA
Exclusion Criteria:
- Patient not able to co-operate
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemonitoring group
Usual care group
Arm Description
Patients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment.
Patients were followed-up during the habituation phase according to hospital's standard procedure.
Outcomes
Primary Outcome Measures
Nursing time
Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records
Secondary Outcome Measures
CPAP adherence measured with in-built clock counter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02509247
Brief Title
Telemonitoring in CPAP Treatment
Acronym
TeleCPAP
Official Title
Telemonitoring in CPAP Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, CPAP, telemonitoring, telecare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemonitoring group
Arm Type
Experimental
Arm Description
Patients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patients were followed-up during the habituation phase according to hospital's standard procedure.
Intervention Type
Device
Intervention Name(s)
Telemonitoring
Other Intervention Name(s)
Restraxx System (ResMed, Sydney, Australia)
Intervention Description
Wireless telemonitoring
Primary Outcome Measure Information:
Title
Nursing time
Description
Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CPAP adherence measured with in-built clock counter
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive adult patients commencing CPAP therapy for OSA
Exclusion Criteria:
Patient not able to co-operate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarja Saaresranta, MD, Phd
Organizational Affiliation
Hospital District of Southwest Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Telemonitoring in CPAP Treatment
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