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Completed

NCT Number: NCT01280006

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Heart Diseases Hypertension Hypoxia Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Hypoxia

Other

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.

Indomethacin

Drug

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.

Other names: Apo-Indomethacin

Celecoxib

Drug

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.

Other names: Celebrex

Placebo

Drug

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 outcomes

  1. Arterial Blood Pressure

    Time frame: Six weeks

    Blood pressure will be monitored during all three protocols.

  2. Cerebral Blood Flow

    Time frame: Six weeks

    The cerebral blood flow will be mesauresed during each testing days of all three protocols.

Secondary outcomes

  1. Ventilatory Response

    Time frame: Six weeks.

    The ventilatory response will be measured during each testing days of all three protocols.

  2. Renal Hemodynamics

    Time frame: Six weeks

    The renal hemodynamics will be measured during each testing days of all three protocols.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2011
Registry last updated
Dec 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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