- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904436
Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to evaluate mechanisms of dyspnea in tetraplegia. This goal will be accomplished by completing the following specific objectives:
- To noninvasively assess dyspnea, motor drive, and respiratory timing during prolonged periods of resting breathing.
- To determine if relationships exist between these breathing pattern components and dyspnea.
- To determine if the relationships among respiratory timing, drive, and dyspnea are altered by a bronchodilator and over its duration of action.
These specific objectives will be used to test the hypotheses that:
- During prolonged periods of resting breathing, respiratory timing will be altered and motor drive will be increased and less variable than in able-bodied controls.
- There will be a positive association between motor drive and dyspnea.
- Improving respiratory mechanics by bronchodilator administration will reduce drive, normalize timing and lessen dyspnea over the duration of action of the drug.
Completion of the proposed studies will expand our existing knowledge of ventilatory control in persons with tetraplegia and relate these changes to dyspnea, a common and distressing clinical problem in these individuals. These studies will also provide a better characterization of breathing patterns and their intrasubject variability in persons with tetraplegia. Currently, the only information regarding breathing patterns in tetraplegia are of limited duration (15-30 minutes). If this pilot study reveals significant relationships between motor drive, timing, and dyspnea, compiling "normative" data for breathing patterns from large numbers of individuals with tetraplegia may be useful in evaluating dyspnea in different clinical settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Bronx, New York, United States, 10468
- VA Medical Center, Bronx
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who have cervical spinal cord injury
- Complaints of dyspnea
- Healthy non-paralyzed controls
Exclusion Criteria:
- Active pulmonary infection
- Current history of chronic pulmonary disease or asthma
- Current smoker (> 0.5 ppd)
- Age < 18 or > 60 years
- Duration of spinal cord injury < 1 year
- Unable to sit upright in a chair or wheelchair for a full day
- Persons taking anticholinergic (e.g., ditropan) or gaba (e.g., baclofen) agents
Study Plan
How is the study designed?
Design Details
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Spinal Cord Injury: subjects who have cervical spinal cord injury and complaints of dyspnea
|
Bronchodilator Treatment: Subjects will inhale 1 unit dose vial of aerosolized ipratropium (500 mcg of ipratropium (Atrovent) mixed in 2.5 ml of saline).
|
No Intervention: 2
Controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The goal of this study is to evaluate ventilatory control during quiet breathing in subjects with tetraplegia by obtaining dyspnea scores and noninvasively measuring indices of motor output (tidal volume / inspiratory time, VT/TI).
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The goal of this study is to evaluate ventilatory control during quiet breathing in subjects with tetraplegia by obtaining dyspnea scores and noninvasively measuring indices of timing (inspiratory time/total breath time TI/TTOT).
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ann M. Spungen, EdD, VA Medical Center, Bronx
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Signs and Symptoms, Respiratory
- Paralysis
- Respiratory Aspiration
- Dyspnea
- Quadriplegia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Ipratropium
Other Study ID Numbers
- B2648C-1
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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