- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06956963
Aerobic Exercise: A Potential Rescue From the Negative Ramifications of Poor Sleep
The goal of this interventional study is to differentiate the effects of an acute partial sleep deprivation intervention on markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing in active vs sedentary individuals. The main aims of the project are:
- To differentiate the effects of partial sleep deprivation on central hemodynamics (i.e., central blood pressure and arterial stiffness) in active vs sedentary individuals.
- To differentiate the effects of partial sleep deprivation on physical (i.e., handgrip strength and reactive strength index) and cognitive performance (i.e., reaction time and impulse control) in active vs sedentary individuals.
- To differentiate the effects of partial sleep deprivation on overall wellbeing (i.e., cardio-autonomic function, inflammation levels, and psychological mood states) in active vs sedentary individuals.
Participants will be divided into two groups based on aerobic activity level - active or sedentary - and assessed for markers of cardiovascular health, cardio-autonomic function, physical and cognitive performance, as well as overall wellbeing before and after three days of normal sleep and three days of partially deprived sleep (i.e., 30% reduction in total time in bed).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brett Cross
- Phone Number: 4783089421
- Email: bcross2@fsu.edu
Study Contact Backup
- Name: Michael Ormsbee
- Email: mormsbee@fsu.edu
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32301
- Recruiting
- Institute of Sports Sciences and Medicine
-
Contact:
- Michael Ormsbee
- Phone Number: 6103313126
- Email: mormsbee@fsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronically active (≥150 minutes of moderate- and/or ≥75 minutes of vigorous-intensity aerobic exercise per week for the last 3 months) OR
- Sedentary (≤60 minutes of aerobic exercise per week for the last 3 months)
Exclusion Criteria:
- Chronic, uncontrolled disease (cardiovascular, metabolic)
- Poor sleep (regularly achieving <7 hours of sleep per night)
- Musculoskeletal injury in the last 6 months
- Obese (grade II or higher)
- Pregnant
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
|
|
|
Experimental: Acute Partial Sleep Deprivation
30% reduction in habitual time in bed
|
30% reduction in habitual time in bed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness (i.e., carotid-femoral pulse wave velocity)
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
Carotid-femoral pulse wave velocity measured via applanation tonometry
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Central Hemodynamics
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
Central Blood Pressure
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardio-Autonomic Function
Time Frame: Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
heart rate variability
|
Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
|
Cardio-Autonomic Function
Time Frame: Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
resting heart rate
|
Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
|
Cardio-Autonomic Function
Time Frame: Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
respiration rate
|
Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
|
Cognitive Performance
Time Frame: Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
impulse control; measured via vetted smart phone application (Sway Medical; Tulsa, OK)
|
Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
|
Cognitive Performance
Time Frame: Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
reaction time; measured via vetted smart phone application (Sway Medical; Tulsa, OK)
|
Daily mid- and post- 3 days of partial sleep deprivation; daily mid- and post- 3 days for normal sleep
|
|
Physical Performance
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
hand grip strength
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Physical Performance
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
reactive strength index; scale title: reactive strength index, scale limits: 0-100, higher value is better
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Inflammation
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
CRP
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Inflammation
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
IL-6
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Inflammation
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
IL-1beta
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Inflammation
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
IL-10
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
|
Inflammation
Time Frame: Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
TNF-alpha
|
Immediately- and 3 days-post 3 days of partial sleep deprivation; Immediately- and 3 days-post 3 days of normal sleep
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- STUDY00006067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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