Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome : a Randomised Controlled Trial of Continuous Positive Airway Pressure Effectiveness (CIH - Gait)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline of stride time coefficient of variation at 8 weeks
研究概览
简要总结
The purpose of this randomised controlled study is to determine the impact of continuous positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait upon severe sleep apnea patients, based on stride time variability.
详细描述
As severe sleep apnea patients exhibit gait abnormalities, this is the first randomised controlled trial to our knowledge to assess the impact of CPAP upon gait and postural control in severe sleep apnea patients. Based on a dual-task paradigm, posture and gait analysis will be perform before and after 8 week of intervention.
Beside gait parameters, the cerebral metabolism will be assessed using a Near Infrared Spectroscopy (fNIRS) device during normal walking and during walking while dual-tasking, using a visual and a verbal task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normally weighted or over-weighted patients (BMI < 30 kilograms/m²)
- •Newly diagnosed Obstructive Sleep Apnea Syndrome (OSAS) (i.e. no previous treatment)
- •Severe OSAS as defined by the American Academy of Sleep Medicine (AHI ≥ 30)
- •To speak and understand french
- •To be affiliated to social welfare
排除标准
- •Age criteria : <18 year old and >70 year old
- •Obesity (BMI ≥ 30 kilograms/m²)
- •Pathological conditions thought to be responsible of gait unsteadiness and postural sway or requiring an walking device : nervous system disease (Parkinson disease, chronic stroke), cerebellum syndrome, vestibular syndrome, orthopaedic and rheumatic diseases,
- •Lower limb sensitivity impairment,
- •Cognitive disorder (Folstein test score < 24),
- •Ophthalmology disorder : uncorrected refractive disorder, disturbance of color vision,
- •Psychotropic treatment intake,
- •Alcoholism,
- •Member of an at-risk occupation (car, bus, truck drivers...) mandating effective continuous positive airway pressure introduction.
结局指标
主要结局
Change from baseline of stride time coefficient of variation at 8 weeks
时间窗: Baseline and 8 weeks
The stride time will be recorded during an overground walking test, under single (walking alone) and dual-task (walking while performing a cognitive task) condition. The cognitive task used in our protocol is an electronic Stroop test, displayed on a screen at the end of the 10 meters walkway. The coefficient of variation allows us to estimate stride time variability, known to be the reflect of gait control efficiency when it exhibits low values.
次要结局
- Change from baseline of gait speed at 8 weeks(Baseline and 8 weeks)
- Change from baseline of step width at 8 weeks(Baseline and 8 weeks)
- Change from baseline of double support time and percentage at 8 weeks(Baseline and 8 weeks)
- Change from baseline of step length at 8 weeks(Baseline and 8 weeks)
- Change from baseline of single support time and percentage at 8 weeks(Baseline and 8 weeks)
- Change from baseline of the center-of-pressure area at 8 weeks(Baseline and 8 weeks)
- Change from baseline of the center-of-pressure mean speed at 8 weeks(Baseline and 8 weeks)
- Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks(Baseline and 8 weeks)
- Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks(Baseline and 8 weeks)
- Change from baseline of the center-of-pressure length at 8 weeks(Baseline and 8 weeks)
- Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks(Baseline and 8 weeks)
研究者
AdministrateurDRC
Directeur de la recherche clinique
University Hospital, Grenoble