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

Primary Purpose

Obstructive Sleep Apnea-hypopnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telemedicine Arm
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea-hypopnea focused on measuring Obstructive sleep apnea-hypopnea, Telemedicine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sleep Disorders Program, UBC Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
November 19, 2007
Last Updated
March 14, 2014
Sponsor
University of British Columbia
Collaborators
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT00561860
Brief Title
Use of a Remote-Monitoring System to Diagnose and Treat Obstructive Sleep Apnea
Official Title
Use of a Remote-Monitoring System to Diagnose and Treat Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea-hypopnea
Keywords
Obstructive sleep apnea-hypopnea, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telemedicine Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
CPAP compliance (3 months) and overall cost of patient care
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najib Ayas, MD, MPH
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Cortes, RT
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Fleetham, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Program, UBC Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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