Characterizing Hypoxic Apnea Intra-individual Repeatability

NCT ID: NCT06399575

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-02

Study Completion Date

2024-06-28

Brief Summary

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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 (i.e., 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

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Conditions

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Hypoxia Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Apnea Following Isocapnic Hypoxia

Group Type EXPERIMENTAL

Apnea Following Isocapnic Hypoxia

Intervention Type OTHER

Decreasing end-tidal partial pressure of oxygen to 50 mmHg for five minutes, targeting 80-85% peripheral oxygen saturation. The end-tidal partial pressure of carbon dioxide will remain +1 mmHg above baseline levels. After five minutes of hypoxia, participants will complete an apnea.

Interventions

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Apnea Following Isocapnic Hypoxia

Decreasing end-tidal partial pressure of oxygen to 50 mmHg for five minutes, targeting 80-85% peripheral oxygen saturation. The end-tidal partial pressure of carbon dioxide will remain +1 mmHg above baseline levels. After five minutes of hypoxia, participants will complete an apnea.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and females between the ages of 18-70

Exclusion Criteria

* Having known cardiovascular or nervous system disease
* Low or high blood pressure (\< 90/60 or \>139/85, respectively)
* Taking any prescribed medications (other than oral contraceptives) that may affect cardiovascular system function
* Females who may be pregnant (self-reported)
* Involved in other studies
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Busch SA, Davies H, van Diepen S, Simpson LL, Sobierajski F, Riske L, Stembridge M, Ainslie PN, Willie CK, Hoiland R, Moore JP, Steinback CD. Chemoreflex mediated arrhythmia during apnea at 5,050 m in low- but not high-altitude natives. J Appl Physiol (1985). 2018 Apr 1;124(4):930-937. doi: 10.1152/japplphysiol.00774.2017. Epub 2017 Dec 21.

Reference Type BACKGROUND
PMID: 29357505 (View on PubMed)

Busch SA, van Diepen S, Steele AR, Meah VL, Simpson LL, Figueroa-Mujica RJ, Vizcardo-Galindo G, Villafuerte FC, Tymko MM, Ainslie PN, Moore JP, Stembridge M, Steinback CD. Global REACH: Assessment of Brady-Arrhythmias in Andeans and Lowlanders During Apnea at 4330 m. Front Physiol. 2020 Jan 22;10:1603. doi: 10.3389/fphys.2019.01603. eCollection 2019.

Reference Type BACKGROUND
PMID: 32038287 (View on PubMed)

Stanforth PR, Gagnon J, Rice T, Bouchard C, Leon AS, Rao DC, Skinner JS, Wilmore JH. Reproducibility of resting blood pressure and heart rate measurements. The HERITAGE Family Study. Ann Epidemiol. 2000 Jul;10(5):271-7. doi: 10.1016/s1047-2797(00)00047-8.

Reference Type BACKGROUND
PMID: 10942874 (View on PubMed)

Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000 Jul;30(1):1-15. doi: 10.2165/00007256-200030010-00001.

Reference Type BACKGROUND
PMID: 10907753 (View on PubMed)

Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. doi: 10.1519/15184.1.

Reference Type BACKGROUND
PMID: 15705040 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00138947

Identifier Type: -

Identifier Source: org_study_id

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