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

NCT ID: NCT02358811

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2023-04-14

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.

Conditions

Obstructive Sleep Apnea (SAOS); Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Eldery SAOS+

Patients with severe obstructive sleep apnea (AHI\>30) 70 years old and more

Magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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.

Cognitive assessment

Intervention Type: BEHAVIORAL

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)

Eldery SAOS-

People without obstructive sleep apnea (AHI\<10) 70 years old and more

Magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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.

Cognitive assessment

Intervention Type: BEHAVIORAL

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)

Adult SAOS+

Patients with severe obstructive sleep apnea (AHI\>30) 18 \< Age \< 55 years old

Magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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.

Cognitive assessment

Intervention Type: BEHAVIORAL

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)

Adult SAOS-

People without obstructive sleep apnea (AHI\<10) 18 \< Age \< 55 years old

Magnetic resonance imaging (MRI)

Intervention Type: DEVICE

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.

Cognitive assessment

Intervention Type: BEHAVIORAL

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)

Interventions

Magnetic resonance imaging (MRI)

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.

Intervention Type: DEVICE

Cognitive assessment

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic ROCHE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2013-A00719-36

Identifier Type: OTHER

Identifier Source: secondary_id

1308014

Identifier Type: -

Identifier Source: org_study_id