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

ConditionsObstructive Sleep Apnea of AdultHypoxia, BrainSleep ApneaSleep DisorderStrokeBlood PressureEndothelial DysfunctionOxidative Stress
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Calgary

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep

    Drug

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

  • Drug Lowering CBF and Intermittent Hypoxia Sleep

    Drug

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

  • Placebo and Normoxia Sleep

    Drug

    The study participants will take Placebo and sleep under Normoxia Exposure

  • Placebo and Intermittent Hypoxia Sleep

    Drug

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

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: CBF Lowering and Normoxia SleepActive comparator 1 intervention
Group B: CBF Lowering and IH SleepExperimental treatment 1 intervention
Group C: Placebo and Normoxia SleepSham comparator 1 intervention
Group D: Placebo and IH SleepPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
~18 months (from the starting time of recruiting study participants)
2

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.

Time frame
~18 months (from the starting time of recruiting study participants)

Secondary outcomes

1

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.

Time frame
~24 months (from the starting time of recruiting study participants)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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