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

July 13, 2020 updated by: Central Hospital Saint Quentin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Quentin, France, 02100
        • Recruiting
        • CH Saint-Quentin
        • Contact:
        • Contact:
        • Principal Investigator:
          • ATTIER-ZMUDKA MS Jadwiga, PH
        • Sub-Investigator:
          • DOUADI M Youcef, ph
        • Sub-Investigator:
          • SOREL ms Claire, ph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 120 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total arterial flowrate (measured by PC-MRI debit ml/Mn)
Time Frame: at day 1 after inclusion
at day 1 after inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital Saint Quentin

Investigators

  • Principal Investigator: ATTIER Jadwiga, MD, CH Saint-Quentin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (ESTIMATE)

October 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB / N° 2014-A01617-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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