Trial record 2 of 195286 for:    ALL

Telemonitoring in CPAP Treatment (TeleCPAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT02509247
First received: June 10, 2015
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Sleep Apnea
Device: Telemonitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemonitoring in CPAP Treatment

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Nursing time [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: August 2012
Study Completion Date: March 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring group
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.
Device: Telemonitoring
Wireless telemonitoring
Other Name: Restraxx System (ResMed, Sydney, Australia)
No Intervention: Usual care group
Patients were followed-up during the habituation phase according to hospital's standard procedure.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive adult patients commencing CPAP therapy for OSA

Exclusion Criteria:

  • Patient not able to co-operate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02509247

Locations
Finland
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Tarja Saaresranta, MD, Phd Hospital District of Southwest Finland
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02509247     History of Changes
Other Study ID Numbers: T200/2013
Study First Received: June 10, 2015
Last Updated: July 23, 2015
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Turku University Hospital:
sleep apnea
CPAP
telemonitoring
telecare

ClinicalTrials.gov processed this record on July 26, 2015