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

NCT00561860 | Completed

• 2 other identifiers: H06-70411C06-0411
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea-hypopnea

Keywords

Obstructive sleep apnea-hypopnea; Telemedicine

Outcome Measures

Primary Outcomes (1)

• CPAP compliance (3 months) and overall cost of patient care

  3 months

Secondary Outcomes (1)

• 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.

  3 months

Study Arms (2)

1

NO INTERVENTION

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.

2

EXPERIMENTAL

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

Interventions

Telemedicine Arm DEVICE

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.

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Philips Respironics: collaborator

Study Sites (1)

Sleep Disorders Program, UBC Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Study Officials

• Najib Ayas, MD, MPH

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Lisa Cortes, RT

  University of British Columbia

  STUDY DIRECTOR

• John Fleetham, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)