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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).
The investigators will explore the relationship between changes in Cerebral Blood Flow (CBF) and ventilatory chemoreflexes i.e. Acute Ventilatory Response to Hypoxia (AHVR) and Acute Hypercapnic Ventilatory Response (HCVR) before, during and after sleep under normoxic conditions and sleep accompanied by isocapnic Intermittent Hypoxia (IH) among healthy human study participants.
A pharmacological intervention will be utilized to manipulate the CBF in a randomized order. The study participants will also be randomly assigned the order to sleep either under normoxia or IH exposure. The experiments will be separated from one another with an interval of sufficient drug and IH exposure washout period. The venous blood samples and urinary samples will be collected for the vascular biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBF Lowering and Normoxia Sleep | Active Comparator | Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure. |
|
| CBF Lowering and IH Sleep | Experimental | Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure. |
|
| Placebo and Normoxia Sleep | Sham Comparator | Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure. |
|
| Placebo and IH Sleep | Placebo Comparator | Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep | Drug | The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cerebral blood flow and ventilatory chemoreflexes | The relationship between changes in cerebral blood flow (CBF) and ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses) before and after sleeping under normoxia and intermittent hypoxia exposure among healthy human study participants. | ~18 months (from the starting time of recruiting study participants) |
| Cerebral blood flow responses and ventilatory chemoreflexes during sleep | The relationship between cerebral blood flow (CBF) changes and ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses) during sleep under normoxia and intermittent hypoxia exposure among healthy human study participants. | ~18 months (from the starting time of recruiting study participants) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in reactive oxygen species and vascular biomarkers | The changes in vascular biomarkers such as nitric oxide, reactive oxygen species and exosome analysis or urinary prostaglandins before and after sleep under normoxia and intermittent hypoxia exposure with cerebral blood flow changes. | ~24 months (from the starting time of recruiting study participants) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 4N1 | Canada |
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| Drug Lowering CBF and Intermittent Hypoxia Sleep | Drug | The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure |
|
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| Placebo and Normoxia Sleep | Drug | The study participants will take Placebo and sleep under Normoxia Exposure |
|
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| Placebo and Intermittent Hypoxia Sleep | Drug | The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D012891 | Sleep Apnea Syndromes |
| D012893 | Sleep Wake Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D050660 | Core Binding Factors |
| D002560 | Cerebrovascular Circulation |
| ID | Term |
|---|---|
| D014157 | Transcription Factors |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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