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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT02345694

Collaborator

Agence Régionale de Santé Rhône-Alpes (Other)

Enrollment

Location

Arms

46.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Syndrome	Device: Effective CPAP Device: Sub-therapeutic CPAP	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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)

Actual Study Start Date :

Feb 3, 2015

Actual Primary Completion Date :

Nov 28, 2018

Actual Study Completion Date :

Dec 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Effective CPAP Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks.	Device: Effective CPAP Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks Other Names: Continuous positive airway pressure (RESMED S9™ Series)
Sham Comparator: 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.	Device: Sub-therapeutic CPAP Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks Other Names: Sham-CPAP (RESMED S9™ Sham-CPAP System)

Arm

Intervention/Treatment

Experimental: Effective CPAP

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

Device: Effective CPAP

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

Other Names:

Continuous positive airway pressure (RESMED S9™ Series)

Sham Comparator: 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.

Device: Sub-therapeutic CPAP

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

Other Names:

Sham-CPAP (RESMED S9™ Sham-CPAP System)

Outcome Measures

Primary Outcome Measures

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

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 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.
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.

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.