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

Central Hospital Saint Quentin

Status

Unknown

Conditions

Alzheimer Disease

Treatments

Other: Vascular flow measurement by PC-MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02578303

RCB / N° 2014-A01617-40

Details and patient eligibility

About

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.

Full 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

Enrollment

139 estimated patients

Sex

All

Ages

75 to 120 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

139 participants in 2 patient groups

Dementia group

Experimental group

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

Treatment:

Other: Vascular flow measurement by PC-MRI

control group

Other group

Description:

Treatment:

Other: Vascular flow measurement by PC-MRI