Testing Drug Lowering Cerebral Blood Flow (CBF) against a placebo for obstructive sleep apnea of adult
Official title: Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia
Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia
- Phase 1
- 4 groups
- One site, in Calgary
- Recruiting
Interventions (4)
- Medication
Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
- Medication
Drug Lowering CBF and Intermittent Hypoxia Sleep
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
- Medication
Placebo and Normoxia Sleep
The study participants will take Placebo and sleep under Normoxia Exposure
- Medication
Placebo and Intermittent Hypoxia Sleep
The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 - 45 years of age
- +Healthy adults
- +Living in Calgary for the past one year
- +Have no medical condition or should not be taking any blood pressure medications.
- +The participant should not be lactose intolerant
Exclusion
- −Drug allergies to non-steroidal anti-inflammatories
- −Cerebrovascular, cardio-respiratory, renal and metabolic diseases
- −Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease
- −Pregnancy, obese and sleep-disordered breathing
- −Currently smoking
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep.
Registry label: A: CBF Lowering and Normoxia Sleep
Group B receives Drug Lowering CBF and Intermittent Hypoxia Sleep.
Registry label: B: CBF Lowering and IH Sleep
Group C, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → and Normoxia Sleep.
Registry label: C: Placebo and Normoxia Sleep
Group D, the placebo group, receives Placebo and Intermittent Hypoxia Sleep.
Registry label: D: Placebo and IH Sleep
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 45 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 12 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: ~18 months (from the starting time of recruitingRecruitingThe study is currently looking for participants.Read more → study participants).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Changes in cerebral blood flow and ventilatory chemoreflexes — measured over ~18 months (from the starting time of recruitingRecruitingThe study is currently looking for participants.Read more → study participants).
Cerebral blood flow responses and ventilatory chemoreflexes during sleep — measured over ~18 months (from the starting time of recruiting study participants).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03255408 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Drug Lowering Cerebral Blood Flow (CBF) and Normoxia SleepDrug
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Drug Lowering CBF and Intermittent Hypoxia SleepDrug
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo and Normoxia SleepDrug
The study participants will take Placebo and sleep under Normoxia Exposure
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo and Intermittent Hypoxia SleepDrug
The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 45 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: ~18 months (from the starting time of recruitingRecruitingThe study is currently looking for participants.Read more → study participants).
The study as a whole is currently expected to finish around 2027-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 12 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.