Effect of CPAP Treatment in Elderly: Randomized Clinical Trial

Sleep Apnea, Obstructive Clinical Trial

Official title:

OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY. ROLE OF CONTINUOUS POSITIVE AIRWAY PRESSURE TREATMENT. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069600
• Other study ID #: RCT-elderly-OSA
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2014
• Last updated: February 20, 2014
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Description:

Not needed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous 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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Fe Valwncia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario La Fe	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurocognitive tests	Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test	Changes in neurocognitive tests from baseline to three months after random	No
Other	Office Blood pressure measurements	3 office Systolic blood pressure and diastolic blood pressure	Changes in blood pressure levels from baseline to three months after random	No
Primary	Quality of life	Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire	Changes in quality baseline from baseline to 3 months after random	No
Secondary	Sleep-related symptoms	Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares	Changes in sleep-related symptoms from baseline to three months after random	No