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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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03255408
Enrollment
12
Registered
2017-08-21
Start date
2023-01-01
Completion date
2027-12-30
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Endothelial Dysfunction, Hypoxia, Brain, Obstructive Sleep Apnea of Adult, Oxidative Stress, Sleep Apnea, Sleep Disorder, Stroke

Brief 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).

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.

Interventions

DRUGDrug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep

The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure

DRUGDrug Lowering CBF and Intermittent Hypoxia Sleep

The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure

DRUGPlacebo and Normoxia Sleep

The study participants will take Placebo and sleep under Normoxia Exposure

DRUGPlacebo and Intermittent Hypoxia Sleep

The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026