Brain During Effort : Effects of Hypoxia With Respiratory Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Brain During Effort : Effects of Hypoxia With Respiratory Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD), Sleep Apnea Obstructive (OSA), Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: Pedalling exercise on a cycle ergometer
* Biological: Isolated contractions of the quadriceps


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronic Obstructive Pulmonary Disease (COPD)<br>18 patients | Biological: Pedalling exercise on a cycle ergometer<br>* At 80% of the maximal aerobic power, until exhaustion<br>Biological: Isolated contractions of the quadriceps<br>* Until exhaustion<br>|
| Active Comparator: Sleep Apnea Obstructive (OSA)<br>18 patients | Biological: Pedalling exercise on a cycle ergometer<br>* At 80% of the maximal aerobic power, until exhaustion<br>Biological: Isolated contractions of the quadriceps<br>* Until exhaustion<br>|
| Active Comparator: Healthy Volunteers<br>36 control patients | Biological: Pedalling exercise on a cycle ergometer<br>* At 80% of the maximal aerobic power, until exhaustion<br>Biological: Isolated contractions of the quadriceps<br>* Until exhaustion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near-infrared spectroscopy (NIRS) | 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. | Half an hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoxia, Brain, Effort