Obstructive Sleep Apnea (SAOS)VOILAGENCT02358811
Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age
An observational study of Obstructive Sleep Apnea (SAOS) and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (SAOS), Aging
- What is being tested?
- Magnetic resonance imaging (MRI) and Cognitive assessment
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2015to 14 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects without SAOS and Patients with SAOS
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Magnetic resonance imaging (MRI), Cognitive assessment
- Keywords
- Obstructive Sleep Apnea, Voxel-Based Morphometry, Polysomnography, Magnetic resonance imaging
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)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 assessmentBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Eldery SAOS+ | Patients with severe obstructive sleep apnea (AHI>30) 70 years old and more Receives: Device: Magnetic resonance imaging (MRI); Behavioral: Cognitive assessment | |
| Eldery SAOS- | People without obstructive sleep apnea (AHI<10) 70 years old and more Receives: Device: Magnetic resonance imaging (MRI); Behavioral: Cognitive assessment | |
| Adult SAOS+ | Patients with severe obstructive sleep apnea (AHI>30) 18 < Age < 55 years old Receives: Device: Magnetic resonance imaging (MRI); Behavioral: Cognitive assessment | |
| Adult SAOS- | People without obstructive sleep apnea (AHI<10) 18 < Age < 55 years old Receives: Device: Magnetic resonance imaging (MRI); Behavioral: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the MRI procedure
Secondary outcomes (3)
Level of grey of each of the voxels of the cerebral white 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).
Measured: During the MRI procedure
Cognitive score
It is the sum of the scores of the following 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)
Measured: At the inclusion
Dosage of the markers of the inflammation
The blood markers of the inflammation are : C reactive protein (CRP US), Il1β, Il6, Il10, Tumor Necrosis Factor(TNFα) et Mitochondrial Pyruvate Carrier 1 (MPC1)
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start30 Jun 2015
- Primary completion6 Mar 2023
- Study completion14 Apr 2023
Why it stopped: change of Magnetic resonance imaging (MRI) research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (SAOS)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358811
- Sponsor's protocol ID
- 1308014
- Other IDs
- 2013-A00719-36
- Acronym
- VOILAGE
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2015
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Sleep Apnea on Cerebral Volumetry According to Age
- ClinicalTrials.gov ID
- NCT02358811
- Acronym / sponsor ID
- VOILAGE / 1308014
- Conditions
- Obstructive Sleep Apnea (SAOS), Aging
- Keywords
- Obstructive Sleep Apnea, Voxel-Based Morphometry, Polysomnography, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: change of Magnetic resonance imaging (MRI) research
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eldery SAOS+ | – | Device: Magnetic resonance imaging (MRI), Behavioral: Cognitive assessmentPatients with severe obstructive sleep apnea (AHI>30) 70 years old and more |
| Eldery SAOS- | – | Device: Magnetic resonance imaging (MRI), Behavioral: Cognitive assessmentPeople without obstructive sleep apnea (AHI<10) 70 years old and more |
| Adult SAOS+ | – | Device: Magnetic resonance imaging (MRI), Behavioral: Cognitive assessmentPatients with severe obstructive sleep apnea (AHI>30) 18 < Age < 55 years old |
| Adult SAOS- | – | Device: Magnetic resonance imaging (MRI), Behavioral: Cognitive assessmentPeople without obstructive sleep apnea (AHI<10) 18 < Age < 55 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects without SAOS and Patients with SAOS
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adult SAOS+, Adult SAOS-, Eldery SAOS+, Eldery SAOS- |
| Cognitive assessmentThis 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) | Behavioural | Adult SAOS+, Adult SAOS-, Eldery SAOS+, Eldery SAOS- |
Primary outcome
Level of grey of each of the voxels of the cerebral grey matter
Time frame: During the MRI procedure
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).
3 secondary outcomes
Level of grey of each of the voxels of the cerebral white matter
Time frame: During the MRI procedure
Cognitive score
Time frame: At the inclusion
Dosage of the markers of the inflammation
Time frame: At the inclusion
Results and safety
The study was stopped early (reason given: change of Magnetic resonance imaging (MRI) research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea (SAOS)
Recruiting
Identification of Biomarkers of Obstructive Sleep Apnea.
Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA)
Recruiting
Home-based Under Mattress Monitor for OSA
Obstructive Sleep Apnea (OSAS), Obstructive Sleep Apnea (SAOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic ROCHE, MD-PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (SAOS) and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change of Magnetic resonance imaging (MRI) research). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of grey of each of the voxels of the cerebral grey matter (time frame: During the MRI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.