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

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascular flow measurement by PC-MRI
Sponsored by
Central Hospital Saint Quentin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring sleep apnea, phase-contrast MRI, cerebral blood flow, vascular risk factor, dementia

Eligibility Criteria

75 Years - 120 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CH Saint-QuentinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dementia group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total arterial flowrate (measured by PC-MRI debit ml/Mn)

Secondary Outcome Measures

sleep apnea measured by elderly polygraphy (Number of apneas / night)

Full Information

First Posted
October 9, 2015
Last Updated
July 13, 2020
Sponsor
Central Hospital Saint Quentin
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1. Study Identification

Unique Protocol Identification Number
NCT02578303
Brief Title
Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Acronym
VAAPS
Official Title
Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital Saint Quentin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
sleep apnea, phase-contrast MRI, cerebral blood flow, vascular risk factor, dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dementia group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Vascular flow measurement by PC-MRI
Intervention Description
participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels
Primary Outcome Measure Information:
Title
Total arterial flowrate (measured by PC-MRI debit ml/Mn)
Time Frame
at day 1 after inclusion
Secondary Outcome Measure Information:
Title
sleep apnea measured by elderly polygraphy (Number of apneas / night)
Time Frame
at day 1 after inclusion up to 24 heures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) 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) Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ATTIER Jadwiga, MD
Phone
0033323067216
Email
j.attier@ch-stquentin.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BOULANOPUAR Abdelkrim, CRA
Phone
0033323067861
Email
a.boulanouar@ch-stquentin.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATTIER Jadwiga, MD
Organizational Affiliation
CH Saint-Quentin
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Saint-Quentin
City
Saint-Quentin
ZIP/Postal Code
02100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ATTIER-ZMUDKA Jadwiga, PH
Phone
0323067861
Email
j.attier@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
BOULANOUAR Abdelkrim, CRA
Phone
0323067861
Email
A.BOULANOUAR@ch-stquentin.fr
First Name & Middle Initial & Last Name & Degree
ATTIER-ZMUDKA MS Jadwiga, PH
First Name & Middle Initial & Last Name & Degree
DOUADI M Youcef, ph
First Name & Middle Initial & Last Name & Degree
SOREL ms Claire, ph

12. IPD Sharing Statement

Plan to Share IPD
No

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

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