Alcohol IntakeNCT02117193
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
A study testing Alcohol intake and Sleep deprivation in people with Alcohol Intake and Sleep Deprivation, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intake, Sleep Deprivation
- What is being tested?
- Alcohol intake and Sleep deprivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical active men
Who cannot join
- AUDIT questionnaire above 15 points
- Nocturnal Chronotype
- Skeletal muscle injuries in upper and lower limb
- Metabolic and cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory
Porto Alegre, Rio Grande do Sul, 90690200
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Intake, Sleep Deprivation
- Being tested
- Alcohol intake, Sleep deprivation
- Medical subject headings
- Alcohol Drinking, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol intakeOther
The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).
Sleep deprivationOther
One night of sleep deprivation or one night of normal sleep.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol intake | Placebo comparator | 1 g/kg of etanol combined. Beer without alcohol in the same volume will be used to placebo condition. Receives: Other: Alcohol intake; Other: Sleep deprivation |
| sleep deprivation | Active comparator | one night of sleep deprivation will be compared to 8h of normal sleep. Receives: Other: Alcohol intake; Other: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Performance
Aerobic performance will be determined through the subject's heart rate
Measured: After each sequence, up to 8 hours
Neuromuscular Performance
knee extensor isometric torque
Measured: After each sequence, up to 8 hours
Biochemical Responses
Glucose after each situation in the morning
Measured: After each sequence, up to 8 hours
Secondary outcomes (3)
Hydration Status
Urine Specific Gravity
Measured: After each sequence, up to 8 hours
Profile of Mood States
Measured: 6 months
Breath Alcohol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Rodrigo Rodrigues, MSc, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117193
- Sponsor's protocol ID
- UFRGS 366465
- Status last verified
- Oct 2016
- First submitted
- 14 Apr 2014
- Last updated
- 21 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Cardiorrespiratory, Neuromuscular and Hormonal Responses in Healthy Males.
- ClinicalTrials.gov ID
- NCT02117193
- Acronym / sponsor ID
- UFRGS 366465
- Conditions
- Alcohol Intake, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Posted 22 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol intake | Placebo comparator | Other: Alcohol intake, Other: Sleep deprivation1 g/kg of etanol combined. Beer without alcohol in the same volume will be used to placebo condition. |
| sleep deprivation | Active comparator | Other: Alcohol intake, Other: Sleep deprivationone night of sleep deprivation will be compared to 8h of normal sleep. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physical active men
Key exclusion criteria (4 listed)
- AUDIT questionnaire above 15 points
- Nocturnal Chronotype
- Skeletal muscle injuries in upper and lower limb
- Metabolic and cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol intakeThe subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation). | Other | Alcohol intake, sleep deprivation |
| Sleep deprivationOne night of sleep deprivation or one night of normal sleep. | Other | Alcohol intake, sleep deprivation |
Primary outcome
Aerobic Performance
Time frame: After each sequence, up to 8 hours
Aerobic performance will be determined through the subject's heart rate
Neuromuscular Performance
Time frame: After each sequence, up to 8 hours
knee extensor isometric torque
Biochemical Responses
Time frame: After each sequence, up to 8 hours
Glucose after each situation in the morning
3 secondary outcomes
Hydration Status
Time frame: After each sequence, up to 8 hours
Profile of Mood States
Time frame: 6 months
Breath Alcohol
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Rodrigues, MSc principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol intake and Sleep deprivation in people with Alcohol Intake and Sleep Deprivation, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Performance (time frame: After each sequence, up to 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.