Alzheimer DiseaseVAAPSNCT02578303
Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
A study testing Vascular flow measurement by PC-MRI in people with Alzheimer Disease, run by Central Hospital Saint Quentin at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. Read more about this study
- Who is it for?
- Ages 75 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Vascular flow measurement by PC-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to 1 Jan 2022
- Phase
- Interventional
- 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 75 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly patients about or over 75 years
- Any gender
- Dementia Group:
- 3.1. MMSE (Mini Mental State Examination)> 15
- 3.2. Diagnosis of dementia established according to DSM-IV
- 3.3. Dementia of the Alzheimer type from NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
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- Control Group:
- Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud
- Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)
Who cannot join
- Elderly patients under 75 years
- Anyone with a classic contraindication to MRI
- 2.1 Major behavioral disorders that do not allow the realization of MRI in optimal conditions
- 2.2 Claustrophobia
- 2.3 Presence of foreign non-compliant material
- 2.4 Presence of intraocular metal body
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- Having a history of chest surgery or neurosurgical
- Chronic respiratory failure
- Suffering from dementia other than that associated with Alzheimer's disease
- Patients with a handicap
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Saint-Quentin
Saint-Quentin, 02100
ATTIER-ZMUDKA Jadwiga, PH, 0323067861, j.attier@ch-stquentin.fr
BOULANOUAR Abdelkrim, CRA, 0323067861, A.BOULANOUAR@ch-stquentin.fr
About this study
Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.
About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.
Read the detailed description
Numerous studies pointed out the close relationship between sleep apnea and cognitive impairment. To the investigators' knowledge, no trials have assessed the existence of a relationship between the IAH index and the cerebral arterial blood flow rate (macrocirculation). Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood flow through phase contrast MRI also called "flow MRI". The main hypothesis tested in this study is the existence of a relationship between OSAS and total cerebral arterial vascular inflow measured by PC-MRI (in mL/min) in the elderly population.
- Primary outcome: The apnea/hypopnea index (measured by nocturnal respiratory polygraphy) and total arterial flow rate (measured by PC-MRI)
- Secondary outcomes:
- Measurement of arrhythmia
- Measurement of arterial blood pressure
- Conditions
- Alzheimer Disease
- Being tested
- Vascular flow measurement by PC-MRI
- Keywords
- sleep apnea, phase-contrast MRI, cerebral blood flow, vascular risk factor, dementia
- Medical subject headings
- Alzheimer Disease, Sleep Apnea Syndromes, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular flow measurement by PC-MRIOther
participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels
| Study group | Role | What they receive |
|---|---|---|
| Dementia group | Experimental | Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia).
ROC method will be used to find a threshold value of IAH that separates the two groups.
Interventions:
* Vascular flow measurement by PC-MRI
* Neuropsychological assessment
* Registration of sleep apnea
* Registration of blood pressure
* ECG holters
* Blood test
* Geriatric standard evaluation Receives: Other: Vascular flow measurement by PC-MRI |
| control group | Other | Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia).
ROC method will be used to find a threshold value of IAH that separates the two groups.
Interventions:
* Vascular flow measurement by PC-MRI
* Neuropsychological assessment
* Registration of sleep apnea
* Registration of blood pressure
* ECG holters
* Blood test
* Geriatric standard evaluation Receives: Other: Vascular flow measurement by PC-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total arterial flowrate (measured by PC-MRI debit ml/Mn)
Measured: at day 1 after inclusion
Secondary outcomes (1)
sleep apnea measured by elderly polygraphy (Number of apneas / night)
Measured: at day 1 after inclusion up to 24 heures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startMay 2015
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital Saint Quentin
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ATTIER Jadwiga, MD, Principal investigator, CH SAINT-QUENTIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578303
- Sponsor's protocol ID
- RCB / N° 2014-A01617-40
- Acronym
- VAAPS
- Status last verified
- Jul 2019
- First submitted
- 9 Oct 2015
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
- ClinicalTrials.gov ID
- NCT02578303
- Acronym / sponsor ID
- VAAPS / RCB / N° 2014-A01617-40
- Conditions
- Alzheimer Disease
- Keywords
- sleep apnea, phase-contrast MRI, cerebral blood flow, vascular risk factor, dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Central Hospital Saint QuentinOther government
- Study start
- May 2015
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 16 Oct 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.
Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.
About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.
Detailed description
Numerous studies pointed out the close relationship between sleep apnea and cognitive impairment. To the investigators' knowledge, no trials have assessed the existence of a relationship between the IAH index and the cerebral arterial blood flow rate (macrocirculation). Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood flow through phase contrast MRI also called "flow MRI". The main hypothesis tested in this study is the existence of a relationship between OSAS and total cerebral arterial vascular inflow measured by PC-MRI (in mL/min) in the elderly population.
- Primary outcome: The apnea/hypopnea index (measured by nocturnal respiratory polygraphy) and total arterial flow rate (measured by PC-MRI)
- Secondary outcomes:
- Measurement of arrhythmia
- Measurement of arterial blood pressure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia group | Experimental | Other: Vascular flow measurement by PC-MRIAssessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia). ROC method will be used to find a threshold value of IAH that separates the two groups. Interventions: * Vascular flow measurement by PC-MRI * Neuropsychological assessment * Registration of sleep apnea * Registration of blood pressure * ECG holters * Blood test * Geriatric standard evaluation |
| control group | Other | Other: Vascular flow measurement by PC-MRIAssessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia). ROC method will be used to find a threshold value of IAH that separates the two groups. Interventions: * Vascular flow measurement by PC-MRI * Neuropsychological assessment * Registration of sleep apnea * Registration of blood pressure * ECG holters * Blood test * Geriatric standard evaluation |
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Elderly patients about or over 75 years
- Any gender
- Dementia Group:
- 3.1. MMSE (Mini Mental State Examination)> 15
- 3.2. Diagnosis of dementia established according to DSM-IV
Key exclusion criteria (11 listed)
- Elderly patients under 75 years
- Anyone with a classic contraindication to MRI
- 2.1 Major behavioral disorders that do not allow the realization of MRI in optimal conditions
- 2.2 Claustrophobia
- 2.3 Presence of foreign non-compliant material
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 |
|---|---|---|
| Vascular flow measurement by PC-MRIparticipants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels | Other | Dementia group, control group |
Primary outcome
Total arterial flowrate (measured by PC-MRI debit ml/Mn)
Time frame: at day 1 after inclusion
1 secondary outcome
sleep apnea measured by elderly polygraphy (Number of apneas / night)
Time frame: at day 1 after inclusion up to 24 heures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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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.
ATTIER Jadwiga, MD principal investigator
CH SAINT-QUENTIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular flow measurement by PC-MRI in people with Alzheimer Disease, run by Central Hospital Saint Quentin 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ATTIER Jadwiga, MD (0033323067216, j.attier@ch-stquentin.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total arterial flowrate (measured by PC-MRI debit ml/Mn) (time frame: at day 1 after inclusion). 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 14 Jul 2020.