Study Stopped
change of Magnetic resonance imaging (MRI) research
Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age
VOILAGE
2 other identifiers
observational
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 9, 2015
CompletedStudy Start
First participant enrolled
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedMarch 13, 2024
March 1, 2024
7.7 years
February 4, 2015
March 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of grey of each of the voxels of the cerebral grey matter
We will use a technique widely used in neuroimage : the voxel-based morphometry (VBM) which allows a precise comparison by assessing local subtle differences at a voxel level (a voxel being a 3D-pixel).
During the MRI procedure
Secondary Outcomes (3)
Level of grey of each of the voxels of the cerebral white matter
During the MRI procedure
Cognitive score
At the inclusion
Dosage of the markers of the inflammation
At the inclusion
Study Arms (4)
Eldery SAOS+
Patients with severe obstructive sleep apnea (AHI\>30) 70 years old and more
Eldery SAOS-
People without obstructive sleep apnea (AHI\<10) 70 years old and more
Adult SAOS+
Patients with severe obstructive sleep apnea (AHI\>30) 18 \< Age \< 55 years old
Adult SAOS-
People without obstructive sleep apnea (AHI\<10) 18 \< Age \< 55 years old
Interventions
The acquisition of the image will last 45 minutes with 6 sequences. * Before any examination, the manipulator will check the absence of contraindication to MRI. * During the fifth sequence, Gadolinium (Gadovist®) will be injected intravenously to the concentration 0.1 mmol / kg. For this, a venous catheter will be placed before the first sequence and then removed after the examination. This injection will be carried out according to the usual practice of MRI. * Throughout the examination, a physician will always be present.
This cognitive assessment will include the following executive tests : * test of Stroop * left Trail Making Test A and B * verbal fluence test * test of memory of figures direct and inverse in order * completion of matrices * Paced Auditory Serial Addition Test (PASAT)
Eligibility Criteria
Healthy subjects without SAOS and Patients with SAOS
You may qualify if:
- or more than 70 years old
- SAOS (AHI\>30) never treated before
- consent form signed
- or more than 70 years old
- No SAOS (AHI\<10)
- consent form signed
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Saint-Etienne
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic ROCHE, MD-PhD
CHU de Saint-Etienne
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 9, 2015
Study Start
June 30, 2015
Primary Completion
March 6, 2023
Study Completion
April 14, 2023
Last Updated
March 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share