Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

Brief Summary

Detailed Description

Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units. So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs. Methods: Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management . Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events...). Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database. Patients of both 2 groups will be finally visited at 3 months at sleep unit.

Primary Outcomes

Secondary Outcomes

• Patients' satisfaction at 3 months(3 months)
• Change in body mass index at 3 months(3 months)
• Change from baseline in quality of life at 3 months(3 months)
• Fast detection of the non-adherent patient with telemonitoring(3 months)
• Change from baseline in snoring at 3 months(3 months)
• Changes in sleep fragmentation at 3 months(3 months)
• Changes in nocturnal gasping at 3 months(3 months)
• Abandons at 3 months(3 months)
• Adverse events at 3 months(3 months)
• Change from baseline in witnessed apneas at 3 months(3 months)
• Presence of symptoms of restlees leg syndrome at 3 months(3 months)
• Cost effectiveness at 3 months(3 months)
• Change in blood pressure at 3 months(3 months)
• Change from baseline in nocturia at 3 months(3 months)
• Change from baseline in daytime sleepiness at 3 months(3 months)