Clinical Trials Directory

Trials / Completed

CompletedNCT01826032

Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Hospital Clinic of Barcelona · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed. The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.

Detailed description

Patients: We will include consecutive patients with a diagnosis of severe OSA (AHI\> 30) without significant comorbidities or excessive daytime sleepiness (Epworth ≤ 12). Patients will be randomized to CPAP treatment or conservative treatment. Methodology: We will assess at baseline and after 3 months of treatment: 1. Neuroimaging by MRI 2. Neurocognitive function with an extensive neuropsychological battery assessing principally memory, attention and executive functions (Trail-making test A and B, Rey Auditory Verbal Learning Test, Digit span, Digit symbol), 3. Biological markers of inflammation and endothelial dysfunction. Patients included in the study will be monitored and followed for three months. They will be examined at the time of inclusion, after two and six weeks and at the end (12 weeks) for clinical monitoring and the evaluation of adaptation to treatment and compliance.

Conditions

Interventions

TypeNameDescription
DEVICECPAPCPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
OTHERStandard care for OSAsleep higiene and dietary counseling

Timeline

Start date
2011-11-01
Primary completion
2014-09-01
Completion
2014-09-01
First posted
2013-04-08
Last updated
2015-01-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01826032. Inclusion in this directory is not an endorsement.