Brain During Effort : Effects of Hypoxia With Respiratory Patients

Healthy Volunteers Clinical Trial

— NEUROX  

Official title:

Brain During Effort : Effects of Hypoxia With Respiratory Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854280
• Other study ID #: 38RC12.212
• Status: Completed
• Phase: N/A
• First received: July 26, 2016
• Last updated: March 5, 2018
• Start date: June 2013
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Healthy Volunteers
• Hypoxia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea Obstructive (OSA)

Intervention

Biological:
• Pedalling exercise on a cycle ergometer
At 80% of the maximal aerobic power, until exhaustion
• Isolated contractions of the quadriceps
Until exhaustion

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

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* Note: There are 79 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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