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临床试验/NCT02578303
NCT02578303Unknown不适用

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

Central Hospital Saint Quentin2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
139
试验地点
2
主要终点
Total arterial flowrate (measured by PC-MRI debit ml/Mn)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
75 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients about or over 75 years
  • Dementia Group:
  • MMSE (Mini Mental State Examination)> 15
  • Diagnosis of dementia established according to DSM-IV
  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: at day 1 after inclusion

次要结局

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

研究者

发起方
Central Hospital Saint Quentin
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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