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Clinical Trials/NCT03255408
NCT03255408
Not yet recruiting
Phase 1

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

University of Calgary0 sites12 target enrollmentJanuary 1, 2023

Overview

Phase
Phase 1
Intervention
Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep
Conditions
Obstructive Sleep Apnea of Adult
Sponsor
University of Calgary
Enrollment
12
Primary Endpoint
Changes in cerebral blood flow and ventilatory chemoreflexes
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marc Poulin

PhD, DPhil, Professor

University of Calgary

Eligibility Criteria

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

Arms & Interventions

CBF Lowering and Normoxia Sleep

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

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

CBF Lowering and IH Sleep

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

Intervention: Drug Lowering CBF and Intermittent Hypoxia Sleep

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.

Intervention: Placebo and Normoxia Sleep

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.

Intervention: Placebo and Intermittent Hypoxia Sleep

Outcomes

Primary Outcomes

Changes in cerebral blood flow and ventilatory chemoreflexes

Time Frame: ~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

Time Frame: ~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))

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