- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117193
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
October 27, 2016 updated by: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Cardiorrespiratory, Neuromuscular and Hormonal Responses in Healthy Males.
Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously.
Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep.
These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life.
However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ten subjects were randomized in four situations after familiarization and control situation: (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined with sleep deprivation.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90690200
- Exercise Research Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Physical active men
Exclusion Criteria:
- AUDIT questionnaire above 15 points
- Nocturnal Chronotype
- Skeletal muscle injuries in upper and lower limb
- Metabolic and cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Alcohol intake
1 g/kg of etanol combined.
Beer without alcohol in the same volume will be used to placebo condition.
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The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).
One night of sleep deprivation or one night of normal sleep.
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Active Comparator: sleep deprivation
one night of sleep deprivation will be compared to 8h of normal sleep.
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The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).
One night of sleep deprivation or one night of normal sleep.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic Performance
Time Frame: After each sequence, up to 8 hours
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Aerobic performance will be determined through the subject's heart rate
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After each sequence, up to 8 hours
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Neuromuscular Performance
Time Frame: After each sequence, up to 8 hours
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knee extensor isometric torque
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After each sequence, up to 8 hours
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Biochemical Responses
Time Frame: After each sequence, up to 8 hours
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Glucose after each situation in the morning
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After each sequence, up to 8 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydration Status
Time Frame: After each sequence, up to 8 hours
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Urine Specific Gravity
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After each sequence, up to 8 hours
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Profile of Mood States
Time Frame: 6 months
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6 months
|
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Breath Alcohol
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rodrigo Rodrigues, MSc, Federal University of Rio Grande do Sul
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
April 14, 2014
First Submitted That Met QC Criteria
April 15, 2014
First Posted (Estimate)
April 17, 2014
Study Record Updates
Last Update Posted (Estimate)
December 21, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRGS 366465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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