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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03255408
• Other study ID #: REB13-0880
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Blood Pressure
• Endothelial Dysfunction
• Hypoxia
• Hypoxia, Brain
• Obstructive Sleep Apnea of Adult
• Oxidative Stress
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	~18 months (from the starting time of recruiting study participants)
Primary	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.	~18 months (from the starting time of recruiting study participants)
Secondary	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.	~24 months (from the starting time of recruiting study participants)