Sleep Apnea CardioVascular Endpoints study – An investigation of continuous positive airway pressure for the treatment of obstructive sleep apnea to prevent cardiovascular disease.
SAVE (Sleep Apnea cardioVascular Endpoints) study An international, multi-centre, open, parallel group, prospective, randomised, controlled trial to determine the effectiveness of treatment with continuous positive airways pressure (CPAP) in addition to standard care in reducing cardiovascular (CV) morbidity and mortality in patients with co-existing CV disease and moderate-severe obstructive sleep apnea (OSA).
Respironics Sleep and Respiratory Research Foundation
2,500 participants
Dec 28, 2008
Interventional
Conditions
Summary
OSA is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times over during sleep. It is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is CPAP. CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients allocated to the CPAP group will be commenced on fixed level CPAP (90th centile of pressures determined during a 1 week treatment period using auto CPAP). Adherence will be monitored using the in-built monitor in each CPAP device. Treatment with CPAP involves a mask placed over the nose, or both the nose and mouth during sleep. The mask is attached via a hose to a CPAP machine, which gently pushes air into the lungs opening the obstructed airways. Treatment will continue for 2-7 years post randomisation depending on the patient’s date of enrolment. In addition, patients will receive standard care of their CV co-morbidities as directed by their regular doctor(s). Patients who continue to use CPAP (even on an intermittent basis) will have the treatment continued indefinitely.
Locations(25)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12608000409370