Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

Phase 1

Completed

• Conditions: Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases; Stroke

• Registration Number: NCT01280006
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Renal Hemodynamics	Six weeks	The renal hemodynamics will be measured during each testing days of all three protocols.
Ventilatory Response	Six weeks.	The ventilatory response will be measured during each testing days of all three protocols.

Trial Locations

Locations (1)

The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary; 🇨🇦 Calgary, Alberta, Canada