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

Sponsor
Central Hospital Saint Quentin (Other)
Overall Status
Unknown status
CT.gov ID
NCT02578303
Collaborator
(none)
139
1
2
80.1
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vascular flow measurement by PC-MRI
N/A

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

Study Type:
Interventional
Anticipated 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 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total arterial flowrate (measured by PC-MRI debit ml/Mn) [at day 1 after inclusion]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

  1. Control Group:

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

  1. 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

  1. Having a history of chest surgery or neurosurgical

  2. Chronic respiratory failure

  3. Suffering from dementia other than that associated with Alzheimer's disease

  4. Patients with a handicap

  5. Patients under legal protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Saint-Quentin Saint-Quentin France 02100

Sponsors and Collaborators

  • Central Hospital Saint Quentin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital Saint Quentin
ClinicalTrials.gov Identifier:
NCT02578303
Other Study ID Numbers:
  • RCB / N° 2014-A01617-40
First Posted:
Oct 16, 2015
Last Update Posted:
Jul 14, 2020
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2020