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

Obstructive Sleep Apnea-hypopnea Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea-hypopnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT00561860
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: September 2010