Sleep Apnea, Obstructive
Conditions
Keywords
Elderly, CPAP, clinical trial, obstructive sleep apnea
Brief summary
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.
Detailed description
Not needed
Interventions
DEVICEContinuous Positive Airway Pressure
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
Sponsors
Instituto de Salud Carlos III
Hospital Universitario La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients were initially eligible for participation in the study if they were aged at least 70 years, had an apnea-hypopnea index (AHI) ≥30 and had signed the informed consent to participate
Exclusion criteria
* Current use of CPAP treatment, central sleep apnea (defined as at least 50% of respiratory events having a pattern of apnea or hypopnea without respiratory effort), respiratory failure (defined as diurnal oxygen saturation below 90%), severe heart failure (NYHA III-IV), a cardiovascular event in the month prior to the inclusion in the study or disabling hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale ≥ 18).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Changes in quality baseline from baseline to 3 months after random | Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep-related symptoms | Changes in sleep-related symptoms from baseline to three months after random | Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive tests | Changes in neurocognitive tests from baseline to three months after random | Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test |
| Office Blood pressure measurements | Changes in blood pressure levels from baseline to three months after random | 3 office Systolic blood pressure and diastolic blood pressure |
Countries
Spain
Outcome results
None listed