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

NCT ID: NCT03255408

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBF Lowering and Normoxia Sleep

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

Group Type ACTIVE_COMPARATOR

Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep

Intervention Type DRUG

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

CBF Lowering and IH Sleep

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

Group Type EXPERIMENTAL

Drug Lowering CBF and Intermittent Hypoxia Sleep

Intervention Type DRUG

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

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.

Group Type SHAM_COMPARATOR

Placebo and Normoxia Sleep

Intervention Type DRUG

The study participants will take Placebo and sleep under Normoxia Exposure

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.

Group Type PLACEBO_COMPARATOR

Placebo and Intermittent Hypoxia Sleep

Intervention Type DRUG

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

Interventions

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Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep

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

Intervention Type DRUG

Drug Lowering CBF and Intermittent Hypoxia Sleep

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

Intervention Type DRUG

Placebo and Normoxia Sleep

The study participants will take Placebo and sleep under Normoxia Exposure

Intervention Type DRUG

Placebo and Intermittent Hypoxia Sleep

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

Intervention Type DRUG

Other Intervention Names

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Cerebral Blood Flow changes and Normoxia Sleep CBF changes and Intermittent Hypoxia Sleep Cerebral Blood Flow (CBF) with Placebo in Normoxia Sleep CBF with Placebo in Intermittent Hypoxia Sleep

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Marc Poulin

PhD, DPhil, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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REB13-0880

Identifier Type: -

Identifier Source: org_study_id

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