Effect of CPAP Treatment in Elderly: Randomized Clinical Trial

Phase 3

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Continuous Positive Airway Pressure

• Registration Number: NCT02069600
• Lead Sponsor: Hospital Universitario La Fe

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

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-20
• Last Update Submitted: 2014-02-20
• Study First Posted: 2014-02-24
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	Continuous Positive Airway Pressure	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sleep-related symptoms	Changes in sleep-related symptoms from baseline to three months after random	Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares

Trial Locations

Locations (1)

Hospital Universitario La Fe Valwncia; 🇪🇸 Valencia, Spain