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

March 17, 2020 updated by: AdministrateurDRC, University Hospital, Grenoble

Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome : a Randomised Controlled Trial of Continuous Positive Airway Pressure Effectiveness (CIH - Gait)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Echirolles, Isère, France, 38130
        • Institut de rééducation, Hôpital Sud, CHU de GRENOBLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of stride time coefficient of variation at 8 weeks
Time Frame: 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.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of single support time and percentage at 8 weeks
Time Frame: 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.
Baseline and 8 weeks
Change from baseline of double support time and percentage at 8 weeks
Time Frame: Baseline and 8 weeks
To assess gait stability, mean double support time will be assess and its coefficient of variation calculate.
Baseline and 8 weeks
Change from baseline of gait speed at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Change from baseline of step length at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Change from baseline of step width at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Change from baseline of the center-of-pressure area at 8 weeks
Time Frame: Baseline and 8 weeks
Studying gait implies posture assessment as the link between gait stability and an efficient postural control is tenuous.
Baseline and 8 weeks
Change from baseline of the center-of-pressure length at 8 weeks
Time Frame: 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.
Baseline and 8 weeks
Change from baseline of the center-of-pressure mean speed at 8 weeks
Time Frame: Baseline and 8 weeks
The mean speed represents a good index of the amount of neuromuscular activity required to regulate postural control.
Baseline and 8 weeks
Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time Frame: 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.
Baseline and 8 weeks
Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time Frame: Baseline and 8 weeks
The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Baseline and 8 weeks
Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time Frame: Baseline and 8 weeks
The total haemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Baseline and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Dual Task Cost (DTC) at 8 weeks
Time Frame: Baseline and 8 weeks
Dual Task Cost = [(Dual Task % correct - Single Task % correct) x 100 / Single Task % correct]
Baseline and 8 weeks
Continuous Positive Airway Pressure Observance at 8 weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Agence Régionale de Santé Rhône-Alpes

Investigators

  • Principal Investigator: Bernard Wuyam, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2015

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

December 7, 2018

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01523-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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