Chronic Obstructive Pulmonary DiseaseDesCoM-1NCT01679782
Involvement of Nervous System in Muscle Weakness in COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé at 1 site in France.
Trial summary
The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Apr 2014
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups of COPD patients and one group with healthy sedentary subjects
Who may be able to join
- COPD Patients at stage 2 and 3
- Healthy sedentary subjects
Who cannot join
- Epilepsy, pace-maker, nervous disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.
The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.
Read the detailed description
COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, nervous system, peripheral muscle dysfunction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD nocturnal desaturator | COPD patients who spend 30% of the nigth with a SaO2 < 90%. | |
| COPD no nocturnal desaturator | COPD patients who spend less than 30% of the night with a SaO2 < 90% | |
| control group | healthy sedentary subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of voluntary activation
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Collaborators
- M2H laboratory, Montpellier University, ANRT, National French Agency for Technological Researches
- Responsible party
- Sponsor
- Investigators
- Alain AV Varray, Pr, Study director, M2H laboratory, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679782
- Sponsor's protocol ID
- FVIE_FA1
- Acronym
- DesCoM-1
- Status last verified
- Mar 2015
- First submitted
- 3 Sep 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alexandre F, Heraud N, Sanchez AM, Tremey E, Oliver N, Guerin P, Varray A. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation. Sleep. 2016 Feb 1;39(2):327-35. doi: 10.5665/sleep.5438.
PubMed 26446126
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.
- ClinicalTrials.gov ID
- NCT01679782
- Acronym / sponsor ID
- DesCoM-1 / FVIE_FA1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, nervous system, peripheral muscle dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Collaborators
- M2H laboratory, Montpellier University, ANRT, National French Agency for Technological Researches
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Sep 2012 (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.
The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.
Detailed description
COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD nocturnal desaturator | – | –COPD patients who spend 30% of the nigth with a SaO2 < 90%. |
| COPD no nocturnal desaturator | – | –COPD patients who spend less than 30% of the night with a SaO2 < 90% |
| control group | – | –healthy sedentary subjects |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of COPD patients and one group with healthy sedentary subjects
Key inclusion criteria (2 listed)
- COPD Patients at stage 2 and 3
- Healthy sedentary subjects
Key exclusion criteria (1 listed)
- Epilepsy, pace-maker, nervous disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of voluntary activation
Time frame: 2h
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 10 Mar 2015.
- Derived from this study: PubMed 26446126Alexandre F, Heraud N, Sanchez AM, Tremey E, Oliver N, Guerin P, Varray A. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation. Sleep. 2016 Feb 1;39(2):327-35. doi: 10.5665/sleep.5438.
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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.
Alain AV Varray, Pr study director
M2H laboratory, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé 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 2 inclusion and 1 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 10 Mar 2015. 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?
Level of voluntary activation (time frame: 2h). 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 NCT01679782, which also lists 1 linked publication.
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 10 Mar 2015.