NCT06679543

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

November 5, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

exercise blood pressurecardiac outputplasma volumesleep deprivation

Outcome Measures

Primary Outcomes (1)

  • cardiac output responses to cycling exercise

    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 Outcomes (2)

  • Blood pressure responses to cycling exercise

    Comparison between normal sleep and partial sleep deprivation, ~3 weeks

  • Plasma volume

    Comparison between normal sleep and partial sleep deprivation, ~3 weeks

Study Arms (2)

Normal sleep

NO INTERVENTION

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.

Partial sleep deprivation

EXPERIMENTAL

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).

Other: Partial sleep deprivation

Interventions

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).

Partial sleep deprivation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Julian Bommarito, MSc

    University of Guelph

    STUDY DIRECTOR
  • Philip Millar, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Bommarito, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

January 2, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

IPD used in the results publication

Time Frame
Beginning after publication with no end date

Locations