Status:
TERMINATED
Sleep Apnea in Early to Mid-Stage Alzheimer's Disease
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Association Lyonnaise de Logistique Posthospitalière
Conditions:
Early Onset Alzheimer Disease
Alzheimer Disease
Eligibility:
All Genders
65+ years
Brief Summary
Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher in patients with de...
Detailed Description
This study's originality lies in that the target population is elderly and has been diagnosed with both Alzheimer's disease and sleep apnea, and in that it focuses on the impact of treatment on these ...
Eligibility Criteria
Inclusion
- Diagnosis of Alzheimer-type dementia confirmed by the study's memory specialist.
- MMS comprised between 20 and 28 (inclusive)
- One main caregiver with full mental capacity, living under the same roof, present at all medical visits
- Patient covered by compulsory health insurance
- Patient signed the informed consent form
Exclusion
- Prior diagnosis of sleep apnea or patients already benefitting from respiratory assistance equipment- History of COPD (Chronic Obstructive Pulmonary Disease), treated with bronchodilators or corticoids
- Patients with severe heart failure (stages III and IV of the NYHA Functional Classification)
- Patients with a recent history of stroke or myocardial infarction (within the last three months)
- Recently initiated or modified anticholinergic treatment (within the last two months)
- Patients under guardianship
- Behavioral disorders (pacing, agitation)
- Patients with severe dementia
- Patient with potentially low tolerance to treatment (latex allergies, claustrophobia, prior CPAP treatment which was badly tolerated)
- Serious bullous lung disease
- Pneumothorax
- Arterial hypotension
- Dehydration
- Cerebrospinal fluid effusion, recent concussion, or cranial surgery
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01400542
Start Date
December 1 2010
End Date
June 1 2014
Last Update
August 11 2016
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France, 42000