- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00561860
Use of a Remote-Monitoring System to Diagnose and Treat Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2B5
- Sleep Disorders Program, UBC Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CPAP compliance (3 months) and overall cost of patient care
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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3 months
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Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H06-70411
- C06-0411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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