Completed

NCT Number: NCT02854280

Brain During Effort : Effects of Hypoxia With Respiratory Patients

Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the modification of one or the other can affect the neuronal O2 availability.

Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and therefore of the CBF, can create an important dizziness between the demand and the supply of cerebral O2.

It seems that hypoxia can trouble in a significant way the response of central neurons, just as the production of a motor cortex generated motor command.

Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat for brain oxygenation and the motor command, with the consequence a decrease of the exercise performance.

This projects aim to study effects of hypoxia on the brain function for patients suffering from chronic respiratory disease. Neurophysiologic responses of the brain while resting or exercising, including drip and cerebral oxygenation, cortical excitation and motor command resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz in blood.

The study will use a multidisciplinary and supplementary methodological approach : the near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF, neurostimulation procedures and electromyography (EMG) to appreciate the cortical excitability, measure the level of central activation and motor command.

The goals of this study will be :

* Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of voluntary activation and central fatigue to the effort for the chronic hypoxemic patient compared to healthy control subjects. * Analyse disruptions of locomotion parameters and posturographyc, in simple and double task, involving different levels of cerebral task. * Analyse acute effects of an improvement of arterial oxygenation for patients suffering from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation, cortical excitability, mechanisms of voluntary activation and central fatigue. * Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for patients suffering from obstructive sleep apnea (OSA) with the same parameters.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Apnea Chronic Disease Disease Attributes Dyssomnias Healthy Volunteers Hypoxia Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Obstructive (OSA) Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

COPD patients

stages GOLD III - IV, FEV1/FVC ratio < 0,7 and maximum voluntary ventilation (MVV) < 50% of predicted values
BMI < 30 kg/m²
Age between 18 and 80 years
Non-smoking or ex-smoker (stop since more than 3 months)
Stable condition since more than 3 months
PaCO2 < 45 mmHg resting with ambiant air
No OSA diagnostic

OSA patients

Severe OSA recently dignosed (apnoea-Hypopnoea Index (AHI) > 30)
Score on Epworth Sleepiness Scale (ESS) > 10
Age between 18 and 80 years
BMI < 30 kg/m²

Control subjects

Age between 18 and 80 years
BMI < 30 kg/m²
Non-smoker
Without any chronic respiratory pathology, cardiovascular, metabolic, renal or neuromuscular, vestibular and/or visual disorder

Exclusion criteria

OSA and COPD patients

Pathologies cardiovascular, neuromuscular, métabolic, renal
Alcoholism
BMI > 30 kg/m²
Psychiatric disorders or history of behavioural disorders, vision disorders, vestibular disorders, neurologic disease sensitive to disrupt the postural control and the walking, cognitive disorders
Instability since less than 3 months
Counter argument to the application of an external magnetic field

Control subjects

Respiratory pathologies, cardiovascular, neuromuscular, metabolic, renal
Alcoholism
BMI > 30 kg/m²
Psychiatric disorders or history of behavioural disorders
Counter argument to the application of an external magnetic field

Treatment and study plan

Pedalling exercise on a cycle ergometer

Biological

At 80% of the maximal aerobic power, until exhaustion

Isolated contractions of the quadriceps

Biological

Until exhaustion

Primary outcomes

Near-infrared spectroscopy (NIRS)

Time frame: Half an hour

Quantities of total desoxyhemoglobin and hemoglobin at muscular and cerebral levels while resting or during effort in response to inhalation of variable fractions of O2 and CO2.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: NEUROX

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2018
First posted: Aug 3, 2016
Registry last updated: Mar 7, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed