Back to resultsEffect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
Primary Purpose
Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Intermittent hypoxia
Indomethacin
Celecoxib
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Hypoxia, Sleep, Blood Pressure, Hypertension, Myocardial Infarction, Stroke, Ventilation, Brain, Cerebral Blood Flow, Renal Blood Flow
Eligibility Criteria
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
Sites / Locations
- The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary
Outcomes
Primary Outcome Measures
Arterial Blood Pressure
Blood pressure will be monitored during all three protocols.
Cerebral Blood Flow
The cerebral blood flow will be mesauresed during each testing days of all three protocols.
Secondary Outcome Measures
Ventilatory Response
The ventilatory response will be measured during each testing days of all three protocols.
Renal Hemodynamics
The renal hemodynamics will be measured during each testing days of all three protocols.
Full Information
NCT ID
NCT01280006
First Posted
January 18, 2011
Last Updated
December 2, 2011
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT01280006
Brief Title
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
Official Title
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure.
Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure
Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases, Stroke
Keywords
Obstructive Sleep Apnea, Hypoxia, Sleep, Blood Pressure, Hypertension, Myocardial Infarction, Stroke, Ventilation, Brain, Cerebral Blood Flow, Renal Blood Flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Intermittent hypoxia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Other Intervention Name(s)
Apo-Indomethacin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arterial Blood Pressure
Description
Blood pressure will be monitored during all three protocols.
Time Frame
Six weeks
Title
Cerebral Blood Flow
Description
The cerebral blood flow will be mesauresed during each testing days of all three protocols.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Ventilatory Response
Description
The ventilatory response will be measured during each testing days of all three protocols.
Time Frame
Six weeks.
Title
Renal Hemodynamics
Description
The renal hemodynamics will be measured during each testing days of all three protocols.
Time Frame
Six weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Poulin, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24815497
Citation
Beaudin AE, Pun M, Yang C, Nicholl DD, Steinback CD, Slater DM, Wynne-Edwards KE, Hanly PJ, Ahmed SB, Poulin MJ. Cyclooxygenases 1 and 2 differentially regulate blood pressure and cerebrovascular responses to acute and chronic intermittent hypoxia: implications for sleep apnea. J Am Heart Assoc. 2014 May 9;3(3):e000875. doi: 10.1161/JAHA.114.000875.
Results Reference
derived
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Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
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