Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia

NCT03255408 — Phase 1 / Phase 2, Recruiting, 12 participants, University of Calgary

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Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia

Registry	NCT03255408
Status	Recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	12 (Estimated)
Sponsor	University of Calgary (Other)
Conditions	Obstructive Sleep Apnea of Adult, Hypoxia, Brain, Sleep Apnea, Sleep Disorder, Stroke, Blood Pressure, Endothelial Dysfunction, Oxidative Stress
Interventions	Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep, Drug Lowering CBF and Intermittent Hypoxia Sleep, Placebo and Normoxia Sleep, Placebo and Intermittent Hypoxia Sleep (Drug)
Dates	start 2023-01-01, primary completion 2027-12-30 (estimated), completion 2027-12-30 (estimated), first posted 2017-08-21, last updated 2026-05-01
Locations	1 site in Canada

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
CBF Lowering and Normoxia Sleep	Active comparator	Drug: Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep	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	Drug: Drug Lowering CBF and Intermittent Hypoxia Sleep	Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.
Placebo and Normoxia Sleep	Sham comparator	Drug: Placebo and Normoxia Sleep	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	Drug: Placebo and Intermittent Hypoxia Sleep	Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep (Drug), also known as Cerebral Blood Flow changes and Normoxia Sleep: The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
Drug Lowering CBF and Intermittent Hypoxia Sleep (Drug), also known as CBF changes and Intermittent Hypoxia Sleep: The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
Placebo and Normoxia Sleep (Drug), also known as Cerebral Blood Flow (CBF) with Placebo in Normoxia Sleep: The study participants will take Placebo and sleep under Normoxia Exposure
Placebo and Intermittent Hypoxia Sleep (Drug), also known as CBF with Placebo in Intermittent Hypoxia Sleep: The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure

+Outcome measures

Primary outcomes

Changes in cerebral blood flow and ventilatory chemoreflexes [~18 months (from the starting time of recruiting study participants)]: 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.
Cerebral blood flow responses and ventilatory chemoreflexes during sleep [~18 months (from the starting time of recruiting study participants)]: 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.

Secondary outcomes

Changes in reactive oxygen species and vascular biomarkers [~24 months (from the starting time of recruiting study participants)]: 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.

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adults
* 18 - 45 years of age
* 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 Criteria:

* Cerebrovascular, cardio-respiratory, renal and metabolic diseases
* Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease
* Pregnancy, obese and sleep-disordered breathing
* Drug allergies to non-steroidal anti-inflammatories
* Currently smoking

+Locations (1)

Facility	City	Country	Status
University of Calgary	Calgary, Alberta	Canada	Recruiting

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