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Recruiting NCT03255408

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

Phase I / Phase II Interventional Obstructive Sleep Apnea of Adult Hypoxia, Brain Sleep Apnea Sleep Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea of Adult, Hypoxia, Brain, Sleep Apnea, Sleep Disorder. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • 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
  • Drug Placebo and Normoxia Sleep
    The study participants will take Placebo and sleep under Normoxia Exposure
  • Drug Placebo and Intermittent Hypoxia Sleep
    The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure

Primary outcome measures

  • Changes in cerebral blood flow and ventilatory chemoreflexes [Time frame: ~18 months (from the starting time of recruiting study participants)]
  • Cerebral blood flow responses and ventilatory chemoreflexes during sleep [Time frame: ~18 months (from the starting time of recruiting 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Canada · 1 center
  • University of Calgary — Calgary

Identifiers

NCT: NCT03255408 · REB13-0880

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗