Brain During Effort : Effects of Hypoxia With Respiratory Patients (NEUROX)

March 5, 2018 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Half an hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Patrick Levy, Professor, Grenoble Hospital University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC12.212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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