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RecruitingNCT03255408Updated May 1, 2026

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

A Phase 1/2 interventional study of Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep and Drug Lowering CBF and Intermittent Hypoxia Sleep in Obstructive Sleep Apnea of Adult, Hypoxia, Brain and Sleep Apnea, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Calgary · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea of Adult
  • Hypoxia, Brain
  • Sleep Apnea
  • Sleep Disorder
  • Stroke
  • Blood Pressure
  • Endothelial Dysfunction
  • Oxidative Stress
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    CBF Lowering and Normoxia Sleep

    Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.

    Drug: Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep

  • Experimental
    CBF Lowering and IH Sleep

    Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

    Drug: Drug Lowering CBF and Intermittent Hypoxia Sleep

  • Sham comparator
    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.

    Drug: Placebo and Normoxia Sleep

  • Placebo comparator
    Placebo and IH Sleep

    Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

    Drug: Placebo and Intermittent Hypoxia Sleep

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

    Also known as: Cerebral Blood Flow changes and Normoxia Sleep

  • 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

    Also known as: CBF changes and Intermittent Hypoxia Sleep

  • DrugPlacebo and Normoxia Sleep

    The study participants will take Placebo and sleep under Normoxia Exposure

    Also known as: Cerebral Blood Flow (CBF) with Placebo in Normoxia Sleep

  • DrugPlacebo and Intermittent Hypoxia Sleep

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

    Also known as: CBF with Placebo in Intermittent Hypoxia Sleep

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: ~18 months (from the starting time of recruiting study participants)

  2. 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.

    Time frame: ~18 months (from the starting time of recruiting study participants)

Secondary outcomes

  1. 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.

    Time frame: ~24 months (from the starting time of recruiting study participants)

06

Study locations

1 of 1 sites recruiting
  • University of Calgary
    Calgary, Alberta T2N 4N1, Canada
    • Chair, Conjoint Ethics Board · Contact · chreb@ucalgary.ca
    Recruiting
07

Registry details

Key details

Study ID
NCT03255408
Lead sponsor
University of Calgary
Responsible party
Marc Poulin (PhD, DPhil, Professor, University of Calgary) — Principal investigator
First posted
Aug 21, 2017
Start date
Jan 1, 2023
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
May 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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