Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)

University Hospital, Grenoble24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Effective CPAPDEVICE

Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks

Sub-therapeutic CPAPDEVICE

Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut de rééducation, Hôpital Sud, CHU de GRENOBLE

Échirolles, Isère, France

Outcomes

Primary Outcomes

Change from baseline of stride time coefficient of variation at 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.