Obstructive Sleep ApneaPhase 1/2NCT01280006
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans
A Phase 1/2 study testing Intermittent hypoxia, Indomethacin and Celecoxib in people with Obstructive Sleep Apnea and Hypertension, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases
- What is being tested?
- Intermittent hypoxia, Indomethacin and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- 18 - 45 years of age
- Informed written consent
Who cannot join
- Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Laboratory of Human Cerebrovascular Physiology, HMRB 209 & HMRB 230, University of Calgary
Calgary, Alberta, T2N 4N1
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases, Stroke
- Being tested
- Intermittent hypoxia, Indomethacin, Celecoxib, Placebo
- Keywords
- Obstructive Sleep Apnea, Hypoxia, Sleep, Blood Pressure, Hypertension, Myocardial Infarction, Stroke, Ventilation, Brain, Cerebral Blood Flow, Renal Blood Flow
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Cardiovascular Diseases, Stroke, Hypoxia, Myocardial Infarction, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxiaOther
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.
IndomethacinDrug
Also called Apo-Indomethacin
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.
CelecoxibDrug
Also called Celebrex
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.
PlaceboDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Pressure
Blood pressure will be monitored during all three protocols.
Measured: Six weeks
Cerebral Blood Flow
The cerebral blood flow will be mesauresed during each testing days of all three protocols.
Measured: Six weeks
Secondary outcomes (2)
Ventilatory Response
The ventilatory response will be measured during each testing days of all three protocols.
Measured: Six weeks.
Renal Hemodynamics
The renal hemodynamics will be measured during each testing days of all three protocols.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Poulin, University of Calgary
- Investigators
- Marc J Poulin, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280006
- Sponsor's protocol ID
- UC-MMHAP-COX-IH-2010001
- Status last verified
- Dec 2011
- First submitted
- 18 Jan 2011
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24815497
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01280006
- Acronym / sponsor ID
- UC-MMHAP-COX-IH-2010001
- Conditions
- Obstructive Sleep Apnea, Hypertension, Cardiovascular Diseases, Stroke
- Keywords
- Obstructive Sleep Apnea, Hypoxia, Sleep, Blood Pressure, Hypertension, Myocardial Infarction, Stroke, Ventilation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- 18 - 45 years of age
- Informed written consent
Key exclusion criteria (1 listed)
- Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent hypoxiaThe 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. | Other | – |
| IndomethacinAlso: Apo-IndomethacinThe 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. | Drug | – |
| CelecoxibAlso: CelebrexThe 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. | Drug | – |
| PlaceboThe 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. | Drug | – |
Primary outcome
Arterial Blood Pressure
Time frame: Six weeks
Blood pressure will be monitored during all three protocols.
Cerebral Blood Flow
Time frame: Six weeks
The cerebral blood flow will be mesauresed during each testing days of all three protocols.
2 secondary outcomes
Ventilatory Response
Time frame: Six weeks.
Renal Hemodynamics
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
- Derived from this study: PubMed 24815497Beaudin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc J Poulin, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intermittent hypoxia, Indomethacin and Celecoxib in people with Obstructive Sleep Apnea and Hypertension, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Pressure (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.