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

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep Drug
    Other Names: Cerebral Blood Flow changes and Normoxia Sleep
    Intervention Desc: The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
    ARM 1: Kind: Experimental
    Label: CBF Lowering and Normoxia Sleep
    Description: Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.
  • Drug Lowering CBF and Intermittent Hypoxia Sleep Drug
    Other Names: CBF changes and Intermittent Hypoxia Sleep
    Intervention Desc: The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
    ARM 1: Kind: Experimental
    Label: CBF Lowering and IH Sleep
    Description: Study participants will take drug lowering Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.
  • Placebo and Normoxia Sleep Drug
    Other Names: Cerebral Blood Flow (CBF) with Placebo in Normoxia Sleep
    Intervention Desc: The study participants will take Placebo and sleep under Normoxia Exposure
    ARM 1: Kind: Experimental
    Label: Placebo and Normoxia Sleep
    Description: Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under room air i.e. normoxia exposure.
  • Placebo and Intermittent Hypoxia Sleep Drug
    Other Names: CBF with Placebo in Intermittent Hypoxia Sleep
    Intervention Desc: The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
    ARM 1: Kind: Experimental
    Label: Placebo and IH Sleep
    Description: Study participants will take Placebo that has no effect on Cerebral Blood Flow (CBF) and sleep under Intermittent Hypoxia (IH) exposure.

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in cerebral blood flow and ventilatory chemoreflexes ~18 months (from the starting time of recruiting study participants)
Primary Cerebral blood flow responses and ventilatory chemoreflexes during sleep ~18 months (from the starting time of recruiting study participants)
Secondary Changes in reactive oxygen species and vascular biomarkers ~24 months (from the starting time of recruiting study participants)

Sponsors