Chronic Obstructive Pulmonary Disease (COPD)NEUROXNCT02854280
Brain During Effort : Effects of Hypoxia With Respiratory Patients
A study testing Pedalling exercise on a cycle ergometer and Isolated contractions of the quadriceps in people with Chronic Obstructive Pulmonary Disease (COPD) and Sleep Apnea Obstructive (OSA), run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Sleep Apnea Obstructive (OSA), Healthy Volunteers
- What is being tested?
- Pedalling exercise on a cycle ergometer and Isolated contractions of the quadriceps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Sleep Apnea Obstructive (OSA), Healthy Volunteers
- Being tested
- Pedalling exercise on a cycle ergometer, Isolated contractions of the quadriceps
- Keywords
- Hypoxia, Brain, Effort
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedalling exercise on a cycle ergometerBiological
At 80% of the maximal aerobic power, until exhaustion
Isolated contractions of the quadricepsBiological
Until exhaustion
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Active comparator | 18 patients Receives: Biological: Pedalling exercise on a cycle ergometer; Biological: Isolated contractions of the quadriceps |
| Sleep Apnea Obstructive (OSA) | Active comparator | 18 patients Receives: Biological: Pedalling exercise on a cycle ergometer; Biological: Isolated contractions of the quadriceps |
| Healthy Volunteers | Active comparator | 36 control patients Receives: Biological: Pedalling exercise on a cycle ergometer; Biological: Isolated contractions of the quadriceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (80)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Levy, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854280
- Sponsor's protocol ID
- 38RC12.212
- Acronym
- NEUROX
- Status last verified
- Mar 2018
- First submitted
- 26 Jul 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ainslie PN, Poulin MJ. Ventilatory, cerebrovascular, and cardiovascular interactions in acute hypoxia: regulation by carbon dioxide. J Appl Physiol (1985). 2004 Jul;97(1):149-59. doi: 10.1152/japplphysiol.01385.2003. Epub 2004 Mar 5.
PubMed 15004003Amann M, Romer LM, Subudhi AW, Pegelow DF, Dempsey JA. Severity of arterial hypoxaemia affects the relative contributions of peripheral muscle fatigue to exercise performance in healthy humans. J Physiol. 2007 May 15;581(Pt 1):389-403. doi: 10.1113/jphysiol.2007.129700. Epub 2007 Feb 22.
PubMed 17317739ASTRAND PO, CUDDY TE, SALTIN B, STENBERG J. CARDIAC OUTPUT DURING SUBMAXIMAL AND MAXIMAL WORK. J Appl Physiol. 1964 Mar;19:268-74. doi: 10.1152/jappl.1964.19.2.268. No abstract available.
PubMed 14155294Barnes M, Goldsworthy UR, Cary BA, Hill CJ. A diet and exercise program to improve clinical outcomes in patients with obstructive sleep apnea--a feasibility study. J Clin Sleep Med. 2009 Oct 15;5(5):409-15.
PubMed 19961023Bassett DR Jr, Howley ET. Limiting factors for maximum oxygen uptake and determinants of endurance performance. Med Sci Sports Exerc. 2000 Jan;32(1):70-84. doi: 10.1097/00005768-200001000-00012.
PubMed 10647532Bedard MA, Montplaisir J, Richer F, Rouleau I, Malo J. Obstructive sleep apnea syndrome: pathogenesis of neuropsychological deficits. J Clin Exp Neuropsychol. 1991 Nov;13(6):950-64. doi: 10.1080/01688639108405110.
PubMed 1779033Beebe DW, Groesz L, Wells C, Nichols A, McGee K. The neuropsychological effects of obstructive sleep apnea: a meta-analysis of norm-referenced and case-controlled data. Sleep. 2003 May 1;26(3):298-307. doi: 10.1093/sleep/26.3.298.
PubMed 12749549Bergh U, Ekblom B, Astrand PO. Maximal oxygen uptake "classical" versus "contemporary" viewpoints. Med Sci Sports Exerc. 2000 Jan;32(1):85-8. doi: 10.1097/00005768-200001000-00013.
PubMed 10647533Bhambhani Y, Malik R, Mookerjee S. Cerebral oxygenation declines at exercise intensities above the respiratory compensation threshold. Respir Physiol Neurobiol. 2007 May 14;156(2):196-202. doi: 10.1016/j.resp.2006.08.009. Epub 2006 Aug 30.
PubMed 17045853Blomstrand E. Amino acids and central fatigue. Amino Acids. 2001;20(1):25-34. doi: 10.1007/s007260170063.
PubMed 11310928Brugniaux JV, Hodges AN, Hanly PJ, Poulin MJ. Cerebrovascular responses to altitude. Respir Physiol Neurobiol. 2007 Sep 30;158(2-3):212-23. doi: 10.1016/j.resp.2007.04.008. Epub 2007 May 1.
PubMed 17544954Calbet JA, Boushel R, Radegran G, Sondergaard H, Wagner PD, Saltin B. Why is VO2 max after altitude acclimatization still reduced despite normalization of arterial O2 content? Am J Physiol Regul Integr Comp Physiol. 2003 Feb;284(2):R304-16. doi: 10.1152/ajpregu.00156.2002. Epub 2002 Oct 3.
PubMed 12388462Canessa N, Castronovo V, Cappa SF, Aloia MS, Marelli S, Falini A, Alemanno F, Ferini-Strambi L. Obstructive sleep apnea: brain structural changes and neurocognitive function before and after treatment. Am J Respir Crit Care Med. 2011 May 15;183(10):1419-26. doi: 10.1164/rccm.201005-0693OC. Epub 2010 Oct 29.
PubMed 21037021Cannizzaro G, Garbin L, Clivati A, Pesce LI. Correction of hypoxia and hypercapnia in COPD patients: effects on cerebrovascular flow. Monaldi Arch Chest Dis. 1997 Feb;52(1):9-12.
PubMed 9151513Celli BR. Predictors of mortality in COPD. Respir Med. 2010 Jun;104(6):773-9. doi: 10.1016/j.rmed.2009.12.017. Epub 2010 Apr 22.
PubMed 20417082
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain During Effort : Effects of Hypoxia With Respiratory Patients
- ClinicalTrials.gov ID
- NCT02854280
- Acronym / sponsor ID
- NEUROX / 38RC12.212
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Sleep Apnea Obstructive (OSA), Healthy Volunteers
- Keywords
- Hypoxia, Brain, Effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Active comparator | Biological: Pedalling exercise on a cycle ergometer, Biological: Isolated contractions of the quadriceps18 patients |
| Sleep Apnea Obstructive (OSA) | Active comparator | Biological: Pedalling exercise on a cycle ergometer, Biological: Isolated contractions of the quadriceps18 patients |
| Healthy Volunteers | Active comparator | Biological: Pedalling exercise on a cycle ergometer, Biological: Isolated contractions of the quadriceps36 control patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedalling exercise on a cycle ergometerAt 80% of the maximal aerobic power, until exhaustion | Biological | Chronic Obstructive Pulmonary Disease (COPD), Healthy Volunteers, Sleep Apnea Obstructive (OSA) |
| Isolated contractions of the quadricepsUntil exhaustion | Biological | Chronic Obstructive Pulmonary Disease (COPD), Healthy Volunteers, Sleep Apnea Obstructive (OSA) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Background: PubMed 15004003Ainslie PN, Poulin MJ. Ventilatory, cerebrovascular, and cardiovascular interactions in acute hypoxia: regulation by carbon dioxide. J Appl Physiol (1985). 2004 Jul;97(1):149-59. doi: 10.1152/japplphysiol.01385.2003. Epub 2004 Mar 5.
- Background: PubMed 17317739Amann M, Romer LM, Subudhi AW, Pegelow DF, Dempsey JA. Severity of arterial hypoxaemia affects the relative contributions of peripheral muscle fatigue to exercise performance in healthy humans. J Physiol. 2007 May 15;581(Pt 1):389-403. doi: 10.1113/jphysiol.2007.129700. Epub 2007 Feb 22.
- Background: PubMed 14155294ASTRAND PO, CUDDY TE, SALTIN B, STENBERG J. CARDIAC OUTPUT DURING SUBMAXIMAL AND MAXIMAL WORK. J Appl Physiol. 1964 Mar;19:268-74. doi: 10.1152/jappl.1964.19.2.268. No abstract available.
- Background: PubMed 19961023Barnes M, Goldsworthy UR, Cary BA, Hill CJ. A diet and exercise program to improve clinical outcomes in patients with obstructive sleep apnea--a feasibility study. J Clin Sleep Med. 2009 Oct 15;5(5):409-15.
- Background: PubMed 10647532Bassett DR Jr, Howley ET. Limiting factors for maximum oxygen uptake and determinants of endurance performance. Med Sci Sports Exerc. 2000 Jan;32(1):70-84. doi: 10.1097/00005768-200001000-00012.
- Background: PubMed 1779033Bedard MA, Montplaisir J, Richer F, Rouleau I, Malo J. Obstructive sleep apnea syndrome: pathogenesis of neuropsychological deficits. J Clin Exp Neuropsychol. 1991 Nov;13(6):950-64. doi: 10.1080/01688639108405110.
- Background: PubMed 12749549Beebe DW, Groesz L, Wells C, Nichols A, McGee K. The neuropsychological effects of obstructive sleep apnea: a meta-analysis of norm-referenced and case-controlled data. Sleep. 2003 May 1;26(3):298-307. doi: 10.1093/sleep/26.3.298.
- Background: PubMed 10647533Bergh U, Ekblom B, Astrand PO. Maximal oxygen uptake "classical" versus "contemporary" viewpoints. Med Sci Sports Exerc. 2000 Jan;32(1):85-8. doi: 10.1097/00005768-200001000-00013.
- Background: PubMed 17045853Bhambhani Y, Malik R, Mookerjee S. Cerebral oxygenation declines at exercise intensities above the respiratory compensation threshold. Respir Physiol Neurobiol. 2007 May 14;156(2):196-202. doi: 10.1016/j.resp.2006.08.009. Epub 2006 Aug 30.
- Background: PubMed 11310928Blomstrand E. Amino acids and central fatigue. Amino Acids. 2001;20(1):25-34. doi: 10.1007/s007260170063.
- Background: PubMed 17544954Brugniaux JV, Hodges AN, Hanly PJ, Poulin MJ. Cerebrovascular responses to altitude. Respir Physiol Neurobiol. 2007 Sep 30;158(2-3):212-23. doi: 10.1016/j.resp.2007.04.008. Epub 2007 May 1.
- Background: PubMed 12388462Calbet JA, Boushel R, Radegran G, Sondergaard H, Wagner PD, Saltin B. Why is VO2 max after altitude acclimatization still reduced despite normalization of arterial O2 content? Am J Physiol Regul Integr Comp Physiol. 2003 Feb;284(2):R304-16. doi: 10.1152/ajpregu.00156.2002. Epub 2002 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Levy, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedalling exercise on a cycle ergometer and Isolated contractions of the quadriceps in people with Chronic Obstructive Pulmonary Disease (COPD) and Sleep Apnea Obstructive (OSA), run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near-infrared spectroscopy (NIRS) (time frame: Half an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854280, which also lists 80 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.