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Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations (VAAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02578303
Recruitment Status : Unknown
Verified July 2019 by Central Hospital Saint Quentin.
Recruitment status was:  Recruiting
First Posted : October 16, 2015
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital Saint Quentin

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Vascular flow measurement by PC-MRI Not Applicable

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:

    1. Measurement of arrhythmia
    2. Measurement of arterial blood pressure
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 139 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Study Start Date : May 2015
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dementia group

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
 Other: Vascular flow measurement by PC-MRI
participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels
control group

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
 Other: Vascular flow measurement by PC-MRI
participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels


Outcome Measures
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Primary Outcome Measures :
  1. Total arterial flowrate (measured by PC-MRI debit ml/Mn) [ Time Frame: at day 1 after inclusion ]

Secondary Outcome Measures :
  1. sleep apnea measured by elderly polygraphy (Number of apneas / night) [ Time Frame: at day 1 after inclusion up to 24 heures ]

Eligibility Criteria
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Ages Eligible for Study:   75 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Elderly patients about or over 75 years
  2. Any gender

  3. 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)

  4. Control Group:

    Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud

  5. Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)

Exclusion Criteria:

  1. Elderly patients under 75 years

  2. 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

  3. Having a history of chest surgery or neurosurgical
  4. Chronic respiratory failure
  5. Suffering from dementia other than that associated with Alzheimer's disease
  6. Patients with a handicap
  7. Patients under legal protection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578303


Contacts
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Contact: ATTIER Jadwiga, MD 0033323067216 j.attier@ch-stquentin.fr
Contact: BOULANOPUAR Abdelkrim, CRA 0033323067861 a.boulanouar@ch-stquentin.fr

Locations
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France
CH Saint-Quentin Recruiting
Saint-Quentin, France, 02100
Contact: ATTIER-ZMUDKA Jadwiga, PH    0323067861    j.attier@ch-stquentin.fr   
Contact: BOULANOUAR Abdelkrim, CRA    0323067861    A.BOULANOUAR@ch-stquentin.fr   
Principal Investigator: ATTIER-ZMUDKA MS Jadwiga, PH         
Sub-Investigator: DOUADI M Youcef, ph         
Sub-Investigator: SOREL ms Claire, ph         
Sponsors and Collaborators
Central Hospital Saint Quentin
Investigators
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Principal Investigator: ATTIER Jadwiga, MD CH Saint-Quentin
More Information
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Responsible Party: Central Hospital Saint Quentin
ClinicalTrials.gov Identifier: NCT02578303    
Other Study ID Numbers: RCB / N° 2014-A01617-40
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital Saint Quentin:
sleep apnea
phase-contrast MRI
cerebral blood flow
vascular risk factor
dementia
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders