Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID03255408

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

Led by University of Calgary · Updated on 2026-05-01

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how changes in cerebral blood flow affect breathing responses during sleep in healthy adults. The study focuses on the body's ventilatory reactions to low oxygen (hypoxia) and high carbon dioxide (hypercapnia) levels, both under normal oxygen conditions and during intermittent low oxygen exposure. This double-blind, placebo-controlled, randomized crossover trial aims to better understand these relationships over approximately 18 months. Participants will receive a drug designed to lower cerebral blood flow or a placebo in a random order. They will sleep under two different conditions: normal oxygen (normoxia) and intermittent low oxygen (intermittent hypoxia). Each participant experiences all combinations of drug/placebo and sleep conditions, with washout periods between exposures. Blood and urine samples will be collected to measure vascular and oxidative stress biomarkers. During the study, participants undergo assessments of cerebral blood flow and ventilatory responses before, during, and after sleep. Researchers will monitor breathing stability and collect samples for reactive oxygen species and vascular biomarker analysis over about 24 months. The study includes detailed monitoring of ventilatory chemoreflexes and cerebral blood flow changes to understand ventilatory stability during sleep.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults
  • Between 18 and 45 years of age
  • Living in Calgary for at least one year
  • No medical conditions and not taking blood pressure medications
  • Not lactose intolerant
Not Eligible

You will not qualify if you...

  • Cerebrovascular, cardio-respiratory, renal, or metabolic diseases
  • Bleeding disorders or upper gastrointestinal diseases such as peptic ulcer disease
  • Pregnancy, obesity, or sleep-disordered breathing
  • Allergies to non-steroidal anti-inflammatory drugs
  • Current smoking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Variable washout interval between exposures

Participants undergo baseline assessments and preparation before starting the experimental conditions.

Multiple visits depending on crossover schedule

Treatment

Duration - Each exposure separated by sufficient washout; total study duration up to 18 months

Participants take either a drug lowering cerebral blood flow or placebo and sleep under normoxia or intermittent hypoxia conditions in a randomized crossover design.

Several in-person visits for drug administration and sleep monitoring sessions

Sample Collection

Duration - Throughout the treatment period as scheduled

Venous blood and urinary samples are collected for vascular biomarker analysis.

Collected during treatment visits

Trial Site Locations

Total: 1 location

1

University of Calgary

Calgary, Alberta, Canada, T2N 4N1

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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