Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)
- Conditions
- Obstructive Sleep Apnea Syndrome
- Interventions
- Device: Effective CPAPDevice: Sub-therapeutic CPAP
- Registration Number
- NCT02345694
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Effective CPAP Effective CPAP Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks. Sub-therapeutic CPAP Sub-therapeutic CPAP Sub-therapeutic Continuous Positive Airway Pressure (RESMED S9™ Sham-Continuous Positive Airway Pressure System), validated placebo of Continuous Positive Airway Pressure, all the nights, during 8 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline of stride time coefficient of variation at 8 weeks 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.
- Secondary Outcome Measures
Name Time Method 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 the center-of-pressure area at 8 weeks Baseline and 8 weeks Studying gait implies posture assessment as the link between gait stability and an efficient postural control is tenuous.
Change from baseline of the center-of-pressure mean speed at 8 weeks Baseline and 8 weeks The mean speed represents a good index of the amount of neuromuscular activity required to regulate postural control.
Change from baseline of double support time and percentage at 8 weeks Baseline and 8 weeks To assess gait stability, mean double support time will be assess and its coefficient of variation calculate.
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 To assess gait stability, mean single support time will be assess under single (walking alone) and dual task condition (walking while performing a cognitive task) and its coefficient of variation calculate.
Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks Baseline and 8 weeks The oxyhaemoglobin concentration will be recorded during an treadmill 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 placed in front of the patient.
We use a fNIRS (Near Infrared Spectroscopy) device, disposed bilaterally opposite to prefrontal cortices to assess the change of oxyhemoglobin concentration over different motor and cognitive tasks.Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks Baseline and 8 weeks The total haemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Change from baseline of the center-of-pressure length at 8 weeks Baseline and 8 weeks Combined with center-of-pressure (CoP) area, the length (path of CoP) of CoP permits efficient measurement of CoP spatial variability.
Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks Baseline and 8 weeks The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Trial Locations
- Locations (1)
Institut de rééducation, Hôpital Sud, CHU de GRENOBLE
🇫🇷Echirolles, Isère, France