- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06679543
Effects of Partial Sleep Deprivation on Cardiac Output During Cycling
The goal of this clinical trial is to determine if attenuations in cardiac output drive the blunted blood pressure response during cycling exercise following a night of partial sleep deprivation in young healthy adults (%50 females). The secondary outcome is to assess sex differences. The main questions it aims to answer are:
- Do reductions in plasma volume drive reductions in cardiac output and therefore blood pressure during exercise following a night of partial sleep deprivation?
- Do sex differences exist?
Participants will:
- Visit the lab after a night of normal sleep and a night of partial sleep deprivation.
- Keep a daily diary of their sleep and food/beverage intake.
- Perform maximal and submaximal exercise on a cycle ergometer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators recently published data showing systolic blood pressure is attenuated during cycling exercise in males but not females following acute partial sleep deprivation, compared to a night of normal sleep, despite no differences in power output. The mechanisms responsible for this sex difference remain unknown. The investigators have pilot data that suggests males have a reduction in cardiac output following acute partial sleep deprivation, but females do not. Therefore, the primary purpose of this study is to assess hemodynamics (blood pressure, stroke volume, and cardiac output) and plasma volume during cycling exercise following a night of normal sleep and partial sleep deprivation in otherwise healthy males and females.
Thirty young healthy adults (50% female) will be recruited to undergo three visits. The first visit will assess maximal oxygen uptake to determine aerobic fitness and metabolic exercise intensity zones. The following two testing visits will be randomized and will be completed after a night of normal sleep or acute partial sleep deprivation (early awakening, 40% normal sleep duration). Sleep will be measured 1-week before each visit subjectively (questionnaire) to determine habitual sleep timing and duration and objectively (wrist actigraphy) the night before each testing visit. Each testing visit will require participants to complete a constant load 60-minute bout of cycling. Before, during, and after the exercise protocol, the investigators will measure hemodynamics and plasma volume. Venous blood samples will be collected via intravenous lines.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julian Bommarito, MSc
- Phone Number: 9052209829
- Email: jbomma01@uoguelph.ca
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- Recruiting
- University of Guelph
-
Contact:
- Julian Bommarito, MSc
- Phone Number: 9052209829
- Email: jbomma01@uoguelph.ca
-
Sub-Investigator:
- Julian Bommarito, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Free of known cardiovascular or metabolic diseases or sleep disorders
- No history of smoking (within the past 3 months)
- Able to engage in physical activity assessed through the physical activity readiness questionnaire (PAR-Q+)
- No prescription of chronic medications other than oral contraceptives
- Able to abide by sleep protocols for all visits
- Individuals who are not allergic to ultrasound gel
- Individuals who are not pregnant
Exclusion Criteria:
- Individuals diagnosed with cardiovascular or metabolic disease or sleep disorders
- Has a history of smoking (within the past 3 months)
- Not ready to engage in physical activity as assessed by the PAR-Q+
- Individuals prescribed chronic medications other than oral contraceptives
- Unable to abide by sleep protocols for any testing visit
- Allergic to ultrasound gel
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Normal sleep
During this arm, participants will be asked to come to the lab for testing after a night of normal sleep.
Normal sleep will be defined as participants habitual sleep-wake timing.
|
|
|
Experimental: Partial sleep deprivation
During this arm, participants will be asked to come to the lab for testing after a night of partial sleep deprivation.
Participants will be asked to fall asleep at their habitual bedtime but wake up early (~40% of normal sleep duration).
|
Participants will be asked to come to the lab for testing after a night of partial sleep deprivation.
Participants will be asked to fall asleep at their habitual bedtime but wake up early (~40% of normal sleep duration).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cardiac output responses to cycling exercise
Time Frame: Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
Cardiac output during exercise after a night of normal sleep and after a night of partial sleep deprivation
|
Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure responses to cycling exercise
Time Frame: Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
Blood pressure during exercise after a night of normal sleep and after a night of partial sleep deprivation
|
Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
|
Plasma volume
Time Frame: Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
Plasma volume after a night of normal sleep and after a night of partial sleep deprivation
|
Comparison between normal sleep and partial sleep deprivation, ~3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Millar, PhD, University of Guelph
- Study Director: Julian Bommarito, MSc, University of Guelph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-03-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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