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

NCT03255408 | Recruiting Phase 1

• 1 other identifier: REB13-0880
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (1)

• Changes in reactive oxygen species and vascular biomarkers

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

Study Arms (4)

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.

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

CBF Lowering and IH Sleep

EXPERIMENTAL

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

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.

Drug: Placebo and Normoxia Sleep

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.

Drug: Placebo and Intermittent Hypoxia Sleep

Interventions

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

Also known as: Cerebral Blood Flow changes and Normoxia Sleep

CBF Lowering and Normoxia Sleep

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

Also known as: CBF changes and Intermittent Hypoxia Sleep

CBF Lowering and IH Sleep

Placebo and Normoxia Sleep DRUG

The study participants will take Placebo and sleep under Normoxia Exposure

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

Placebo and Normoxia Sleep

Placebo and Intermittent Hypoxia Sleep DRUG

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

Also known as: CBF with Placebo in Intermittent Hypoxia Sleep

Placebo and IH Sleep

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Hypoxia, Brain; Sleep Apnea Syndromes; Sleep Wake Disorders; Stroke

Interventions

Core Binding Factors; Cerebrovascular Circulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Transcription Factors; Proteins; Amino Acids, Peptides, and Proteins; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DPhil, Professor

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 21, 2017
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)