A Phase 3 interventional study of Continuous Positive Airway Pressure in Sleep Apnea, Obstructive, sponsored by Hospital Universitario La Fe. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2014-02-24.
Sponsored by Hospital Universitario La Fe · Phase 3, Interventional, and Treatment
Rationale: Almost all the information the investigators have about the effect of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from randomized clinical trials including only middle-aged patients. Little is know, however, about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP treatment in elderly patients with severe OSA on clinical, quality-of-life and neurocognitive spheres. Methods and Measurements: Open-label, randomized, multicenter clinical trial of parallel groups with blinded end-point design conducted in 12 Spanish teaching hospitals on a consecutive clinical cohort of elderly (≥ 70 years) patients with confirmed severe OSA (IAH≥ 30) receiving CPAP or no therapy while maintaining their usual control for three months. CPAP titration was performed by an auto CPAP device. A good adherence was set as at least 4 hours/day of CPAP use. Primary endpoint was the measurement of quality of life by the Quebec Sleep questionnaire, which includes diurnal and nocturnal symptoms, hypersomnolence, and social and emotional dimensions. Secondary endpoints include different sleep-related symptoms, presence of anxiety or depression, office blood pressure figures and some neurocognitive tests. Patients were invited to a clinical visit on three occasions to quantify the adherence to CPAP. Intention-to-treat analysis was performed.
Not needed
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 224 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Hospital Universitario La Fe is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Continuous Positive Airway Pressure is a device that apply a positive pressure in the airway to avoid its collapse during sleep during three months in this study
Device: Continuous Positive Airway Pressure
No intervention. No placebo is used. Control group without CPAP treatment during three months
CPAP applies a positive pressure into the airway to avoid its collapse during sleep. The pressure used in each patient is calculate by an auto CPAP device during 3 months. This device calculate the pressure that avoid 95% of sleep-disordered breathing
Also known as: CPAP device from ResMed CO. Sydney.
Quality of life
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
Time frame: Changes in quality baseline from baseline to 3 months after random
Sleep-related symptoms
Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares
Time frame: Changes in sleep-related symptoms from baseline to three months after random
Neurocognitive tests
Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test
Time frame: Changes in neurocognitive tests from baseline to three months after random
Office Blood pressure measurements
3 office Systolic blood pressure and diastolic blood pressure
Time frame: Changes in blood pressure levels from baseline to three months after random
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Fe