Clinical trial NCT02578303: Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Official title: Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: sleep apnea
phase-contrast MRI
cerebral blood flow
vascular risk factor
dementia
Lead sponsor: Central Hospital Saint Quentin
Sponsor class: OTHER_GOV
First posted: 2015-10-16
Enrollment: 139
Sex: ALL
Minimum age (years): 75
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

  1. Measurement of arrhythmia
  2. Measurement of arterial blood pressure

Eligibility 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

Primary outcomes:
measure: Total arterial flowrate (measured by PC-MRI debit ml/Mn)
timeFrame: at day 1 after inclusion
Secondary outcomes:
measure: sleep apnea measured by elderly polygraphy (Number of apneas / night)
timeFrame: at day 1 after inclusion up to 24 heures
Other outcomes:
Locations:
city: Saint-Quentin
country: France
facility: CH Saint-Quentin
Study officials:
affiliation: CH SAINT-QUENTIN
name: ATTIER Jadwiga, MD
role: PRINCIPAL_INVESTIGATOR
References: