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Completed

NCT Number: NCT02345694

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

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de rééducation, Hôpital Sud, CHU de GRENOBLE

Échirolles, Isère, 38130, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Effective CPAP

Device

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

Other names: Continuous positive airway pressure (RESMED S9™ Series)

Sub-therapeutic CPAP

Device

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

Other names: Sham-CPAP (RESMED S9™ Sham-CPAP System)

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Agence Régionale de Santé Rhône-Alpes

Registry information

Official study 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)

Acronym: CIH-Gait

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2015
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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