Clinical trial NCT02358811: Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age
Official title: Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea (SAOS)
Aging
Keywords: Obstructive Sleep Apnea
Voxel-Based Morphometry
Polysomnography
Magnetic resonance imaging
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 69
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects without SAOS and Patients with SAOS

Brief summary: Sleep apnea is a common disease in the general population and more particularly in elderly subjects in whom prevalence can reach 30 % after 70 years old. In adults (\<55 years old) cardiovascular consequences are well known and make sleep apnea treatment necessary. However elderly (\>70 years old) apneic subjects are less symptomatic in terms of sleepiness, they usually present a lower index of respiratory events and cardiovascular consequences in this population are still discussed, driving some authors to consider sleep apnea in the elderly as a specific disease and making the need for a treatment questionable.

In this study the investigators will focus on the comparison between adult and elderly apneic subjects in terms of cognitive and cardiovascular consequences. Adult apneic patients suffer from a decrease of cognitive performance as well as grey matter local atrophy, particularly in the hippocampus and in the frontal lobes. According to fewer studies, white matter can also be affected by a demyelinisation process. These structural modifications are sometimes associated with disorders of executive and memory functions. In the elderly, no clear association can be drawn between cognitive decline and sleep apnea. Moreover, to our knowledge, the cerebral state of elderly symptomatic apneic subjects has mostly not be investigated.

Detailed description: The goal of this project is to evaluate the impact of sleep apnea on the brain according to age. Our hypothesis is that adult apneic subjects would present local cerebral modification in the areas implied in cognition and memory, such as the hippocampus or the frontal areas, whereas elderly patients would present focal affects related to a deficit in the ventilatory and autonomic control without any major cognitive consequences.

Understanding the consequences of sleep apnea according to age could permit to refine the indications of sleep apnea treatment, mainly in elderly patients.

Eligibility criteria: Inclusion Criteria for patients:

* 18-55 or more than 70 years old
* SAOS (AHI\>30) never treated before
* consent form signed

Inclusion Criteria for subjects:

* 18-55 or more than 70 years old
* No SAOS (AHI\<10)
* consent form signed

Exclusion Criteria (subjects and patients) :

* Contraindication in the practice of MRI: pacemaker, metallic cardiac valve, intra-ocular metal part
* Contraindication in the injection of Gadolinium (allergy during a previous radiological examination).
* Type 1 or 2 diabetes
* History of cerebrovascular accident, myocardial infarction, congestive heart failure
* Chronic and/or severe renal insufficiency
* Chronic respiratory failure
* Neurological pathology
* Central origin sleep apnea (AHIcentral \> 15)

Primary outcomes:
measure: Level of grey of each of the voxels of the cerebral grey matter
timeFrame: During the MRI procedure
Secondary outcomes:
measure: Level of grey of each of the voxels of the cerebral white matter
timeFrame: During the MRI procedure
measure: Cognitive score
timeFrame: At the inclusion
measure: Dosage of the markers of the inflammation
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Frederic ROCHE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: