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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Effective CPAP; Device: Sub-therapeutic CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02345694

2014-A01523-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Effective CPAP

Experimental group

Description:

Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks.

Treatment:

Device: Effective CPAP

Sub-therapeutic CPAP

Sham Comparator group

Description:

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.

Treatment:

Device: Sub-therapeutic CPAP