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Trial record 24 of 279 for:    Cerebral Hypoxia

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

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ClinicalTrials.gov Identifier: NCT03255408
Recruitment Status : Not yet recruiting
First Posted : August 21, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Poulin, University of Calgary

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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Hypoxia, Brain Sleep Apnea Sleep Disorder Stroke Blood Pressure Endothelial Dysfunction Oxidative Stress Drug: Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep Drug: Drug Lowering CBF and Intermittent Hypoxia Sleep Drug: Placebo and Normoxia Sleep Drug: Placebo and Intermittent Hypoxia Sleep Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
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
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
Other Name: Cerebral Blood Flow changes 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
The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
Other Name: CBF changes 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
The study participants will take Placebo and sleep under Normoxia Exposure
Other Name: Cerebral Blood Flow (CBF) with Placebo in 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
The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
Other Name: CBF with Placebo in Intermittent Hypoxia Sleep




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Changes in reactive oxygen species and vascular biomarkers [ Time Frame: ~24 months (from the starting time of recruiting study participants) ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Marc Poulin, PhD, DPhil, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03255408     History of Changes
Other Study ID Numbers: REB13-0880
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hypoxia
Hypoxia, Brain
Brain Diseases
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Central Nervous System Diseases