Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C06-0411 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Respironics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP compliance (3 months) and overall cost of patient care | 3 months |
| Measure | Description | 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. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from participating if they:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Program, UBC Hospital | Vancouver | British Columbia | V6T 2B5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
|