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Trial record 2 of 395 for:    Recruiting, Not yet recruiting, Available Studies | "Sleep Apnea Syndromes"

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

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ClinicalTrials.gov Identifier: NCT02345694
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
Agence Régionale de Santé Rhône-Alpes
Information provided by (Responsible Party):
AdministrateurDRC, University Hospital, Grenoble

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 Not Applicable

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  (Clinical Trial)
Estimated 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)
Study Start Date : January 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change from baseline of gait speed at 8 weeks [ Time Frame: Baseline and 8 weeks ]
  4. Change from baseline of step length at 8 weeks [ Time Frame: Baseline and 8 weeks ]
  5. Change from baseline of step width at 8 weeks [ Time Frame: Baseline and 8 weeks ]
  6. 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.

  7. 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.

  8. 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.

  9. 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.


  10. 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.

  11. 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.


Other Outcome Measures:
  1. 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]

  2. Continuous Positive Airway Pressure Observance at 8 weeks [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • Epworth sleepiness scale >10
  • To speak and understand french
  • To be affiliated to social welfare

Exclusion Criteria:

  • Age criteria : <18 year old and >65 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345694


Contacts
Contact: Sébastien BAILLIEUL, Junior +033623574355 sbaillieul@chu-grenoble.fr
Contact: Bernard WUYAM, MD, PhD +033476767227 bwuyam@chu-grenoble.fr

Locations
France
Institut de rééducation, Hôpital Sud, CHU de GRENOBLE Recruiting
Echirolles, Isère, France, 38130
Contact: Sébastien BAILLIEUL, Junior    +0336 23 57 43 55    sbaillieul@chu-grenoble.fr   
Contact: Bernard WUYAM, MD, PhD         
Principal Investigator: Bernard WUYAM, MD, PhD         
Sub-Investigator: Dominic PERENNOU, MD, PhD         
Sub-Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Renaud TAMISIER, MD, PhD         
Sub-Investigator: Stéphane DOUTRELEAU, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Agence Régionale de Santé Rhône-Alpes
Investigators
Principal Investigator: Bernard WUYAM, MD, PhD University Hospital, Grenoble

Publications:
Responsible Party: AdministrateurDRC, Directeur de la recherche clinique, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02345694     History of Changes
Other Study ID Numbers: 2014-A01523-44
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by AdministrateurDRC, University Hospital, Grenoble:
Obstructive Sleep Apnea Syndrome
Gait
Posture
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Apnea
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases