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Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age (VOILAGE)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Aging
Obstructive Sleep Apnea (SAOS)

Treatments

Behavioral: Cognitive assessment
Device: Magnetic resonance imaging (MRI)

Study type

Observational

Funder types

Other

Identifiers

NCT02358811
1308014
2013-A00719-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

69 participants in 4 patient groups

Eldery SAOS+
Description:
Patients with severe obstructive sleep apnea (AHI\>30) 70 years old and more
Treatment:
Device: Magnetic resonance imaging (MRI)
Behavioral: Cognitive assessment
Eldery SAOS-
Description:
People without obstructive sleep apnea (AHI\<10) 70 years old and more
Treatment:
Device: Magnetic resonance imaging (MRI)
Behavioral: Cognitive assessment
Adult SAOS+
Description:
Patients with severe obstructive sleep apnea (AHI\>30) 18 \< Age \< 55 years old
Treatment:
Device: Magnetic resonance imaging (MRI)
Behavioral: Cognitive assessment
Adult SAOS-
Description:
People without obstructive sleep apnea (AHI\<10) 18 \< Age \< 55 years old
Treatment:
Device: Magnetic resonance imaging (MRI)
Behavioral: Cognitive assessment

Trial contacts and locations

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Central trial contact

Sébastien CELLE, PhD

Data sourced from clinicaltrials.gov

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