Clinical trial NCT02345694: Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)
Official title: Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome : a Randomised Controlled Trial of Continuous Positive Airway Pressure Effectiveness (CIH - Gait)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
Gait
Posture
Continuous Positive Airway Pressure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Agence Régionale de Santé Rhône-Alpes
First posted: 2015-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of stride time coefficient of variation at 8 weeks
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change from baseline of single support time and percentage at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of double support time and percentage at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of gait speed at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of step length at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of step width at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of the center-of-pressure area at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of the center-of-pressure length at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of the center-of-pressure mean speed at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change from baseline in Dual Task Cost (DTC) at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Continuous Positive Airway Pressure Observance at 8 weeks
timeFrame: 8 weeks
Locations:
city: Echirolles
country: France
facility: Institut de rééducation, Hôpital Sud, CHU de GRENOBLE
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Bernard WUYAM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allali G, Perrig S, Cleusix M, Herrmann FR, Adler D, Gex G, Armand S, Janssens JP, Pepin JL, Assal F. Gait abnormalities in obstructive sleep apnea and impact of continuous positive airway pressure. Respir Physiol Neurobiol. 2014 Sep 15;201:31-3. doi: 10.1016/j.resp.2014.06.012. Epub 2014 Jul 4.
citation: Celle S, Annweiler C, Camicioli R, Barthelemy JC, Roche F, Beauchet O. Sleep-related breathing disorders and gait variability: a cross-sectional preliminary study. BMC Pulm Med. 2014 Aug 23;14:140. doi: 10.1186/1471-2466-14-140.
citation: Baillieul S, Wuyam B, Perennou D, Tamisier R, Bailly S, Benmerad M, Piscicelli C, Le Roux-Mallouf T, Verges S, Pepin JL. A randomized sham-controlled trial on the effect of continuous positive airway pressure treatment on gait control in severe obstructive sleep apnea patients. Sci Rep. 2021 Apr 29;11(1):9329. doi: 10.1038/s41598-021-88642-5.