search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea of Adult, Hypoxia, Brain, Sleep Apnea

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep
Drug Lowering CBF and Intermittent Hypoxia Sleep
Placebo and Normoxia Sleep
Placebo and Intermittent Hypoxia Sleep
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Sham Comparator

    Placebo Comparator

    Arm Label

    CBF Lowering and Normoxia Sleep

    CBF Lowering and IH Sleep

    Placebo and Normoxia Sleep

    Placebo and IH Sleep

    Arm Description

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

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

    Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.

    Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Changes in reactive oxygen species and vascular biomarkers
    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.

    Full Information

    First Posted
    August 6, 2017
    Last Updated
    November 2, 2022
    Sponsor
    University of Calgary
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03255408
    Brief Title
    Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia
    Official Title
    Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Calgary

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea of Adult, Hypoxia, Brain, Sleep Apnea, Sleep Disorder, Stroke, Blood Pressure, Endothelial Dysfunction, Oxidative Stress

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CBF Lowering and Normoxia Sleep
    Arm Type
    Active Comparator
    Arm Description
    Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.
    Arm Title
    CBF Lowering and IH Sleep
    Arm Type
    Experimental
    Arm Description
    Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.
    Arm Title
    Placebo and Normoxia Sleep
    Arm Type
    Sham Comparator
    Arm Description
    Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.
    Arm Title
    Placebo and IH Sleep
    Arm Type
    Placebo Comparator
    Arm Description
    Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.
    Intervention Type
    Drug
    Intervention Name(s)
    Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep
    Other Intervention Name(s)
    Cerebral Blood Flow changes and Normoxia Sleep
    Intervention Description
    The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
    Intervention Type
    Drug
    Intervention Name(s)
    Drug Lowering CBF and Intermittent Hypoxia Sleep
    Other Intervention Name(s)
    CBF changes and Intermittent Hypoxia Sleep
    Intervention Description
    The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo and Normoxia Sleep
    Other Intervention Name(s)
    Cerebral Blood Flow (CBF) with Placebo in Normoxia Sleep
    Intervention Description
    The study participants will take Placebo and sleep under Normoxia Exposure
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo and Intermittent Hypoxia Sleep
    Other Intervention Name(s)
    CBF with Placebo in Intermittent Hypoxia Sleep
    Intervention Description
    The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
    Primary Outcome Measure Information:
    Title
    Changes in cerebral blood flow and ventilatory chemoreflexes
    Description
    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.
    Time Frame
    ~18 months (from the starting time of recruiting study participants)
    Title
    Cerebral blood flow responses and ventilatory chemoreflexes during sleep
    Description
    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.
    Time Frame
    ~18 months (from the starting time of recruiting study participants)
    Secondary Outcome Measure Information:
    Title
    Changes in reactive oxygen species and vascular biomarkers
    Description
    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.
    Time Frame
    ~24 months (from the starting time of recruiting study participants)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs