NCT01679782

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

September 3, 2012

Last Update Submit

March 9, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, nervous system, peripheral muscle dysfunction

Outcome Measures

Primary Outcomes (1)

  • Level of voluntary activation

    2h

Study Arms (3)

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

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups of COPD patients and one group with healthy sedentary subjects

You may qualify if:

  • COPD Patients at stage 2 and 3
  • Healthy sedentary subjects

You may not qualify if:

  • Epilepsy, pace-maker, nervous disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Souffle La Vallonie

Lodève, 34700, France

Location

Related Publications (1)

  • 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.

    PMID: 26446126DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveNeurologic Manifestations

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNervous System DiseasesSigns and Symptoms

Study Officials

  • Alain AV Varray, Pr

    M2H laboratory, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

FR(1)