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
| Type | Name | Description |
|---|---|---|
| DEVICE | CPAP | CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling |
| OTHER | Standard care for OSA | sleep 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.