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Use of a Remote-Monitoring System to Diagnose and Treat Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00561860
First received: November 19, 2007
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

Although continuous positive airway pressure (CPAP) is an effective therapy for obstructive sleep apnea-hypopnea (OSAH), one of the major impediments to its use is poor compliance. Adherence with CPAP ranges from 50% to 75%, and subjective reports underestimate actual use. The primary objectives are to determine whether a remote monitoring system improves 3 month compliance (average hours of use/night), and reduces the costs of caring for patients with OSAH who are prescribed CPAP.


Condition Intervention
Obstructive Sleep Apnea-hypopnea
Device: Telemedicine Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use of a Remote-Monitoring System to Diagnose and Treat Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • CPAP compliance (3 months) and overall cost of patient care [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CPAP acceptance (proportion of patients who agree to use CPAP), proportion of high CPAP users (>4 hours average per night), subjective sleepiness, satisfaction with CPAP, side effects with CPAP, # changes in therapy, and time to adequate treatment. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
This pathway represents our standard clinical protocol when a patient has been diagnosed with sleep apnea and CPAP therapy is initiated. After prescription of CPAP, all patients will be seen by our CPAP coordinator and oriented to the device during a 20 minute session. Patients are also provided the telephone number of the CPAP coordinator who can be contacted if any problems or questions arise.
Experimental: 2
Telemedicine involves the provision or support of direct clinical care via the application of electronic and communicating technology, including the remote monitoring of health status. By providing patient data early in the course of CPAP prescription, we believe that this technology would be immensely useful in improving compliance and acceptance of the device in patients with sleep apnea.
Device: Telemedicine Arm
Telemedicine involves the provision or support of direct clinical care via the application of electronic and communicating technology, including the remote monitoring of health status. By providing patient data early in the course of CPAP prescription, we believe that this technology would be immensely useful in improving compliance and acceptance of the device in patients with sleep apnea.

Detailed Description:

The purpose of this study is to determine whether a telemedicine monitoring system can improve the care of patients with OSAH. This system allows close monitoring of patients after prescription of CPAP, and will transmit clinically useful physiologic information (i.e., residual sleep apnea, mask leak, applied pressure, compliance with therapy) daily to the patient's healthcare provider. This should allow early detection of problems with appropriate interventions thereby improving early experience with CPAP, reducing the number of patients who discontinue CPAP therapy and improving overall compliance.

The primary objectives are to determine whether a telemedicine system:1)improves 3 month compliance (average hours of use/night), and 2)reduces the costs of caring for patients with moderate to severe OSAH who are prescribed CPAP.

Secondary objectives are to determine whether this system will improve a variety of other outcomes including: 1) CPAP acceptance (proportion of patients who agree to use CPAP), 2) proportion of high CPAP users (>4 hours average per night), 3) subjective sleepiness, 4) satisfaction with CPAP, 5) side effects with CPAP, 6) # changes in therapy, and 7) time to adequate treatment. In addition, the overall satisfaction of this system will also be assessed.

Telemedicine involves the provision or support of direct clinical care via the application of electronic and communicating technology, including the remote monitoring of health status. By providing patient data early in the course of CPAP prescription, we believe that this technology would be immensely useful in improving compliance and acceptance of the device in patients with sleep apnea.

We intend to perform a randomized controlled trial of this system versus standard care in patients with moderate to severe OSAH. Patients will be randomized to either the 'standard care' arm or the 'telemedicine' arm. To minimize allocation bias, randomization will be performed using sequential numbered envelopes.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for a sleep study to rule out sleep apnea at the Sleep Disorders Program, University of British Columbia. All patients with documented moderate to severe OSAH (AHI≥15 events per hour by PSG) who are prescribed CPAP by their regular sleep physician, and who are willing to accept a trial of CPAP would potentially eligible for the trial.
  • Patients must also provide a telephone number that would allow contact during regular office hours if necessary. Patients must also have access to a telephone line in their bedroom that can be used to transmit data with the modem.
  • We have decided to only study patients with moderate to severe disease, as these are the patients who are most at risk of future CV disease and motor vehicle crashes. As such, we believe that improving CPAP compliance in this group of patients would be especially important.

Exclusion Criteria:

Patients will be excluded from participating if they:

  • Are unable/unwilling to provide informed consent
  • Have active cardiopulmonary or psychiatric disease
  • Have previously been treated for OSA, or
  • Do not reside in the greater Vancouver area.
  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: NCT00561860

Locations
Canada, British Columbia
Sleep Disorders Program, UBC Hospital
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
University of British Columbia
Philips Respironics
Investigators
Principal Investigator: Najib Ayas, MD, MPH University of British Columbia
Study Director: Lisa Cortes, RT University of British Columbia
Study Director: John Fleetham, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00561860     History of Changes
Other Study ID Numbers: H06-70411, C06-0411
Study First Received: November 19, 2007
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Obstructive sleep apnea-hypopnea
Telemedicine

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014