Status:
COMPLETED
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Sleep Apnea
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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...
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 t...
Eligibility Criteria
Inclusion
- Men and women ≥ 65 years old.
- Patients diagnosed with OSA with an apnea-hypopnea index per hour \>30.
- Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
- Signed written informed consent.
Exclusion
- Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.
- Any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions.
- Mini Mental State Exam (MMSE) \<24.
- Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
- Previous CPAP treatment.
- Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.
- Patients with \> 50% of central apneas or the presence of Cheyne-Stokes Respiration.
- History of alcohol abuse or dependence.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01826032
Start Date
November 1 2011
End Date
September 1 2014
Last Update
January 22 2015
Active Locations (1)
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1
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036