Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399575
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-21
Brief Title:
Characterizing Hypoxic Apnea Intra-individual Repeatability
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Characterizing the Repeatability and Reproducibility of Cardiovascular Responses to Hypoxic Apneas
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAIR
Brief Summary:
Apneas breath-holds are increasingly being tested in human subjects to understand how the human body operates Apneas decrease heart rate and increase blood pressure These findings are driving current research into the effects of oxygen concentrations on the heart rate and blood pressure responses to apneas and the effect of breath-hold training on these responses The interest in apnea research is three-fold
1 Apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body
2 Elite divers can use findings from research to better their training and performance and
3 The scientific understanding of apneas may translate to a better understanding of sleep apnea
Despite this interest little is known about the repeatability the consistency within a single day and reproducibility the consistency between days in the heart rate and blood pressure responses to apneas This uncertainty limits the scientific interpretations from previous results This study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas The goals of the study are
1 To provide greater certainty to previous results and
2 Inform best practices for future studies
The study requires 20 healthy volunteers 10 females and will measure heart rate blood pressure breathing parameters expired gas concentrations breathing volume and rate and oxygen saturation During the protocol participants will complete two maximal voluntary apneas and five test apneas The test apneas will all be the same length based on the longer of the two maximal voluntary apneas Before each apnea participants will also breathe low oxygen concentrations hypoxia Hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas ie bigger signal-to-noise ratio Participants will complete two identical test sessions on back-to-back days The differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility The investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions
1 Apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body
2 Elite divers can use findings from research to better their training and performance and
3 The scientific understanding of apneas may translate to a better understanding of sleep apnea
Despite this interest little is known about the repeatability the consistency within a single day and reproducibility the consistency between days in the heart rate and blood pressure responses to apneas This uncertainty limits the scientific interpretations from previous results This study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas The goals of the study are
1 To provide greater certainty to previous results and
2 Inform best practices for future studies
The study requires 20 healthy volunteers 10 females and will measure heart rate blood pressure breathing parameters expired gas concentrations breathing volume and rate and oxygen saturation During the protocol participants will complete two maximal voluntary apneas and five test apneas The test apneas will all be the same length based on the longer of the two maximal voluntary apneas Before each apnea participants will also breathe low oxygen concentrations hypoxia Hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas ie bigger signal-to-noise ratio Participants will complete two identical test sessions on back-to-back days The differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility The investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None