Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Obstructive Sleep Apnea Syndrome, Gait, Posture, Continuous Positive Airway Pressure
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.
Interventions
DEVICEEffective CPAP
Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
DEVICESub-therapeutic CPAP
Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks
Sponsors
Agence Régionale de Santé Rhône-Alpes
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 gait speed at 8 weeks | Baseline and 8 weeks | — |
| Change from baseline of step length 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 deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks | Baseline and 8 weeks | The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration. |
| 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 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Dual Task Cost (DTC) at 8 weeks | Baseline and 8 weeks | Dual Task Cost = \[(Dual Task % correct - Single Task % correct) x 100 / Single Task % correct\] |
| Continuous Positive Airway Pressure Observance at 8 weeks | 8 weeks | — |
Countries
France
Outcome results
None listed