Investigators: Gregory J. Schilero, MD &
Miroslav Radulovic, MD
High thoracic and cervical level spinal injuries are associated with respiratory muscle weakness and impaired ability to cough effectively and/or to exhale forcefully. To reduce the tendency to retain secretions and to have a higher susceptibility to pulmonary infections, pharmacologic and mechanical interventions are being investigated to increase respiratory muscle strength and the ability to forcefully cough. In addition, persons with cervical SCI have a much higher prevalence of sleep disordered breathing than that observed in the general population, which may predispose to adverse cardiovascular sequelae. Ongoing studies are better defining the diagnostic criteria, as well as the cardiovascular and neurohormonal responses, to sleep apnea in persons with SCI. In addition, the inability to cough effectively when associated with esophageal dysmotility and acid reflux (gastroesophageal reflux disease or GERD), may result in chronic airway inflammation. Various medications and/or mechanical devices are being tested to strengthen cough, counteract airway inflammation and, ultimately, decrease respiratory symptoms and improve breathing. Disturbances of breathing during sleep are also being studied.
Cardiovascular Responses to Sleep Apnea in Persons with Tetraplegia
Part 1: You will be asked to wear a portable, noninvasive sleep apnea monitor overnight in your own home, as well as complete a few procedures in the pulmonary lab that include lung function, arterial stiffness and a sleep questionnaire.
Part 2: If it is shown that you have moderate to severe sleep apnea from the portable screening device (or you are a negative control subject), you will be asked to participate in the overnight sleep study. Changes in EEG pattern, hemodynamics, cardiac output, breathing patterns, and chemicals in your blood will be monitored.
Entry Criteria: Chronic SCI; cervical Injury; non-smoker.
Time Commitment: Part 1: 1 visit Part 2: 1-2 nights
Reimbursement: Part 1: $50; Part 2: $125/night
Joshua Hobson, MS, CBDT Research Coordinator
(718) 584-9000 ext 3129
Joshua.Hobson@va.gov
Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function between Able-Bodied and SCI Individuals
Part 1: Day 1 & 2: First, you will be asked to perform a series of breathing tests so that we can assess your lung function. Next, a thin flexible pH catheter will be inserted down your esophagus for 24 hours to test for acid reflux. The following day you will be asked to return to the lab to have the catheter removed.
Part 2: Day 3 & 4: If you are an SCI subject and have a positive GERD test during Part 1, you will be asked to participate in the 8 week treatment phase.
Entry Criteria: Chronic SCI; age 18-75; not currently on medications to treat acid reflux; no acute illness; no known respiratory disease; no known disease of the esophagus; non-smoker.
Time Commitment: Part 1: 2 visits (3 hours total); Part 2: 8 weeks of treatment, 2 visits (3 hours total)
Reimbursement: Part 1: $150, Part 2: $150
Tradd Cummings, MS, Research Coordinator
(718) 584-9000 ext. 3128
tradd.cummings@va.gov
Joshua Hobson, MS, CBDT Research Coordinator
(718) 584-9000 ext. 3129
joshua.Hobson@va.gov
The Effects of an Oral Beta-2 Agonist on Respiratory Muscle Strength in SCI
You will be screened for respiratory muscle weakness and enrolled in the randomized placebo control (non-active pill) trial for 5 months that includes 3 parts and a total of 4 visits. Part 1: You will perform a number of tests on lung function and muscle strength, before being given 2 months (8 weeks) of medication. Part 3: After 2 months you will return and complete the same lung function tests and be given a second 2 month supply of medication. Part 3: You will return for post testing of lung function and muscle strength, and finally return after an additional 2 weeks after you stop medication.
Entry Criteria: Chronic SCI; tetraplegia (C3-C8) or high level paraplegia (T1-T6); respiratory muscle weakness; no known lung disease; no known diabetes.
Time Commitment: 18 weeks; 16 weeks of treatment and four visits to the research center.
Reimbursement: 16 weeks of treatment: $300; 4th and final visit: $75
Tiffany Santiago, BS Research Coordinator
(718) 584-9000 ext. 3128
tiffany.santiago@va.gov
Joshua Hobson, MS, CBDT Research Coordinator
(718) 584-9000 ext. 3129
joshua.Hobson@va.gov
A Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Effects and Duration of Action of Tiotropium Bromide on Pulmonary Function in Persons with SCI
The study consists of 2 parts, with each part involving 2 visits. Part 1: On the first visit you will be randomized to use a single dose of the active medication or a placebo (sugar pill). Measurement of pulmonary function tests will be performed before, 1, and 3 hours post-inhaler. For visit 2, you will be asked to return the following day and the same measurements of pulmonary function tests will be performed at 20 and 24 hours post-inhaler. Two weeks later, visit three we will have you will receive the opposite treatment from part 1, and perform the identical procedures. You will be asked to return for visit 4 the following day to complete the 20 and 24 hour post-inhaler testing.
Entry Criteria: Subjects who are 18-65 years of age with SCI between C3 and C8 for at least 1 year.
Time Commitment: 3-4 weeks; 4 visits that will be 3-4 hours each.
Reimbursement: $300 total; $75 each visit.
Tiffany Santiago, BS Research Coordinator
(718) 584-9000 ext. 3128
tiffany.santiago@va.gov
Joshua Hobson, MS, CBDT Research Coordinator
(718) 584-9000 ext. 3129
joshua.Hobson@va.gov
Exhaled nitric oxide levels are elevated in persons with tetraplegia and comparable to that in mild asthmatics.
