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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Effective CPAP
Sub-therapeutic CPAP
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, Gait, Posture, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut de rééducation, Hôpital Sud, CHU de GRENOBLE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Effective CPAP

Sub-therapeutic CPAP

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline of single support time and percentage at 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
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
Change from baseline of step length at 8 weeks
Change from baseline of step width at 8 weeks
Change from baseline of the center-of-pressure area at 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
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
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
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
The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
The total haemoglobin concentration will be recorded as oxyhaemoglobin concentration.

Full Information

First Posted
January 12, 2015
Last Updated
March 17, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Agence Régionale de Santé Rhône-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT02345694
Brief Title
Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)
Acronym
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2015 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
December 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Agence Régionale de Santé Rhône-Alpes

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Obstructive Sleep Apnea Syndrome, Gait, Posture, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effective CPAP
Arm Type
Experimental
Arm Description
Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks.
Arm Title
Sub-therapeutic CPAP
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Effective CPAP
Other Intervention Name(s)
Continuous positive airway pressure (RESMED S9™ Series)
Intervention Description
Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
Intervention Type
Device
Intervention Name(s)
Sub-therapeutic CPAP
Other Intervention Name(s)
Sham-CPAP (RESMED S9™ Sham-CPAP System)
Intervention Description
Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline of stride time coefficient of variation at 8 weeks
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of single support time and percentage at 8 weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of double support time and percentage at 8 weeks
Description
To assess gait stability, mean double support time will be assess and its coefficient of variation calculate.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of gait speed at 8 weeks
Time Frame
Baseline and 8 weeks
Title
Change from baseline of step length at 8 weeks
Time Frame
Baseline and 8 weeks
Title
Change from baseline of step width at 8 weeks
Time Frame
Baseline and 8 weeks
Title
Change from baseline of the center-of-pressure area at 8 weeks
Description
Studying gait implies posture assessment as the link between gait stability and an efficient postural control is tenuous.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of the center-of-pressure length at 8 weeks
Description
Combined with center-of-pressure (CoP) area, the length (path of CoP) of CoP permits efficient measurement of CoP spatial variability.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of the center-of-pressure mean speed at 8 weeks
Description
The mean speed represents a good index of the amount of neuromuscular activity required to regulate postural control.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Description
The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Time Frame
Baseline and 8 weeks
Title
Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Description
The total haemoglobin concentration will be recorded as oxyhaemoglobin concentration.
Time Frame
Baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in Dual Task Cost (DTC) at 8 weeks
Description
Dual Task Cost = [(Dual Task % correct - Single Task % correct) x 100 / Single Task % correct]
Time Frame
Baseline and 8 weeks
Title
Continuous Positive Airway Pressure Observance at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard WUYAM, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de rééducation, Hôpital Sud, CHU de GRENOBLE
City
Echirolles
State/Province
Isère
ZIP/Postal Code
38130
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24999279
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.
Results Reference
background
PubMed Identifier
25150985
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.
Results Reference
background
PubMed Identifier
33927278
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.
Results Reference
derived

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

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