Trial Outcomes & Findings for Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans. (NCT NCT02117193)
NCT ID: NCT02117193
Last Updated: 2016-12-21
Results Overview
Aerobic performance will be determined through the subject's heart rate
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
After each sequence, up to 8 hours
Results posted on
2016-12-21
Participant Flow
Participant milestones
| Measure |
All Study Participants
This is a cross-over study.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Alcohol Intake + Normal Sleep
|
10
|
|
Overall Study
Placebo Intake + Normal Sleep
|
10
|
|
Overall Study
Alcohol Intake + Sleep Deprivation
|
10
|
|
Overall Study
Placebo Intake + Sleep Deprivation
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.5 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=5 Participants
|
|
maximal oxygen uptake
|
44.8 ml.kg-1.min-1
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: After each sequence, up to 8 hoursAerobic performance will be determined through the subject's heart rate
Outcome measures
| Measure |
Sequence 1
n=10 Participants
Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 2
n=10 Participants
Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
Sequence 3
n=10 Participants
Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 4
n=10 Participants
Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
|---|---|---|---|---|
|
Aerobic Performance
|
172 bpm
Standard Deviation 12.19
|
173 bpm
Standard Deviation 9.2
|
175 bpm
Standard Deviation 6.5
|
176 bpm
Standard Deviation 11.4
|
PRIMARY outcome
Timeframe: After each sequence, up to 8 hoursknee extensor isometric torque
Outcome measures
| Measure |
Sequence 1
n=10 Participants
Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 2
n=10 Participants
Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
Sequence 3
n=10 Participants
Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 4
n=10 Participants
Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
|---|---|---|---|---|
|
Neuromuscular Performance
|
260.8 Nm
Standard Deviation 27.9
|
242.3 Nm
Standard Deviation 34.3
|
258.9 Nm
Standard Deviation 31.3
|
249.5 Nm
Standard Deviation 33.9
|
PRIMARY outcome
Timeframe: After each sequence, up to 8 hoursGlucose after each situation in the morning
Outcome measures
| Measure |
Sequence 1
n=10 Participants
Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 2
n=10 Participants
Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
Sequence 3
n=10 Participants
Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 4
n=10 Participants
Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
|---|---|---|---|---|
|
Biochemical Responses
|
89.82 mg/dl
Standard Deviation 6.60
|
84.76 mg/dl
Standard Deviation 4.03
|
92.77 mg/dl
Standard Deviation 5.13
|
92.85 mg/dl
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: After each sequence, up to 8 hoursUrine Specific Gravity
Outcome measures
| Measure |
Sequence 1
n=10 Participants
Alcohol intake + Normal Sleep
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 2
n=10 Participants
Alcohol intake + Sleep deprivation
Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
Sequence 3
n=10 Participants
Placebo intake + Normal Sleep
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Normal sleep: One night of normal sleep (8h)
|
Sequence 4
n=10 Participants
Placebo intake + Sleep deprivation
Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.
Sleep deprivation: One night of sleep deprivation (8h)
|
|---|---|---|---|---|
|
Hydration Status
|
1.017 g/ml
Standard Deviation 0.006
|
1.017 g/ml
Standard Deviation 0.005
|
1.015 g/ml
Standard Deviation 0.003
|
1.011 g/ml
Standard Deviation 0.006
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Alcohol Intake + Normal Sleep
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Alcohol Intake + Sleep Deprivation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Intake + Normal Sleep
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Intake + Sleep Deprivation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alcohol Intake + Normal Sleep
n=10 participants at risk
1 g/kg of etanol combined with 8 hours of normal sleep
|
Alcohol Intake + Sleep Deprivation
n=10 participants at risk
1 g/kg of etanol combined with 8 hours of sleep deprivation
|
Placebo Intake + Normal Sleep
n=10 participants at risk
Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
|
Placebo Intake + Sleep Deprivation
n=10 participants at risk
Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
|
|---|---|---|---|---|
|
Nervous system disorders
Fatigue
|
50.0%
5/10
|
80.0%
8/10
|
0.00%
0/10
|
30.0%
3/10
|
|
Nervous system disorders
Headache
|
50.0%
5/10
|
80.0%
8/10
|
0.00%
0/10
|
30.0%
3/10
|
Additional Information
Dr Marco Aurélio Vaz
Federal University of Rio Grande do Sul
Phone: 555133085860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place