Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Premotor cortex activation in OSAS patients without CPAP
研究概览
简要总结
The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OSAS patients
- •severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h
- •without CPAP treatment
- •Non-OSAS patients
- •absence of OSAS (AHI < 15/h and absence of excessive daytime sleepiness with Epworth score <11)
- •Non-inclusion criteria :
- •< 18 years old
- •>75 years old
- •left-handed
- •BMI> 40 kg/m²
- •another sleep disorder
- •central component of sleep apnea syndrome (central apnea index> 5 / h)
- •current or past neurological pathology
- •respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia)
- •MRI contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.)
- •taking drugs that can modify the BOLD signal on MRI (psychotropic drugs, vasodilators, vasoconstrictors, etc.),
- •uncorrected sensory impairment (vision or hearing)
- •protected by law.
排除标准
- •pregnant woman according to the positive beta-hCG test result
- •left-handed following the laterality questionnaire
- •MINI results showing:
- •a current mood episode
- •a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco)
- •an eating disorder
- •a diagnosis of bipolar disorder, current or past schizophrenia
研究组 & 干预措施
non-OSAS patients
Patients without OSAS (Apnea-Hypopnea Index (AHI) < 15/h and absence of excessive daytime sleepiness with Epworth score <11)
干预措施: functional magnetic resonance imaging (Diagnostic Test)
OSAS patients
Patients with severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h
干预措施: functional magnetic resonance imaging (Diagnostic Test)
结局指标
主要结局
Premotor cortex activation in OSAS patients without CPAP
时间窗: Day 0
次要结局
未报告次要终点