Cardiovascular Diseases, Hypertension, Obstructive Sleep Apnea, Stroke
Conditions
Keywords
Obstructive Sleep Apnea, Hypoxia, Sleep, Blood Pressure, Hypertension, Myocardial Infarction, Stroke, Ventilation, Brain, Cerebral Blood Flow, Renal Blood Flow
Brief summary
The study has been designed to assess the effect of cyclooxygenase inhibition on blood pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic intermittent hypoxia exposure.
Detailed description
The study will specifically evaluate: 1. Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure. 2. Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure 3. Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.
Interventions
DRUGIndomethacin
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia. Indomethacin: 50 mg, Oral, three times per day for five days.
OTHERIntermittent hypoxia
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. On the testing day, the subjects will undergo an acute intermittent hypoxia testing before and six hours of hypoxic chamber exposure mimicking obstructive sleep apnea syndrome.
DRUGCelecoxib
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia. Celecoxib: 200 mg, Oral, two times per day for five days with a visually matching sequential placebo in between of two doses.
DRUGPlacebo
The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia. Placebo: Oral, three times per day for five days.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects * 18 - 45 years of age * Informed written consent
Exclusion criteria
* Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Blood Pressure | Six weeks | Blood pressure will be monitored during all three protocols. |
| Cerebral Blood Flow | Six weeks | The cerebral blood flow will be mesauresed during each testing days of all three protocols. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory Response | Six weeks. | The ventilatory response will be measured during each testing days of all three protocols. |
| Renal Hemodynamics | Six weeks | The renal hemodynamics will be measured during each testing days of all three protocols. |
Countries
Canada
Outcome results
None listed