SleepNCT02082600
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
A study testing Sleep deprivation and Normal sleep in people with Sleep and Sleep Deprivation, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old. Read more about this study
- Who is it for?
- Ages 20 to 31 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Deprivation
- What is being tested?
- Sleep deprivation and Normal sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 31 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- sedentary
- sleep duration between 6-8 hours peer night
Who cannot join
- smokers
- use vitamin supplements, like C and E
- drink two doses of alcohol/day or > 4 doses in one occasion
- use of anti-inflammatory drugs
- antilipidemic drugs
- anemia
Show all 12Show fewer
- muscle or joint diseases
- cardiovascular diseases
- diabetes
- renal diseases
- sleep disturbances
- breathing disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04020-050
About this study
The aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep rebound.
Read the detailed description
The blood parameters analyzed will be:
- Creatine kinase and myoglobin: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol.
- Total and free testosterone, IGF-1, and cortisol: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. Moreover, from 19:00 of the second day to 19:00 of the third day it will be collected blood samples every 2 hours.
- GH: during the second night, GH will be evaluated every 1 hour, from 23:00 to 07:00.
- TNF-alfa, IL-6, IL-1 beta, IL-10, and IL-1ra: before, immediately after, and 2 hour after exercise, as well every 4 hours from 19:00 of the second day to 19:00 of the third day.
It will be evaluated isometric strength every 12 hours, as well visual analog scale of pain.
- Conditions
- Sleep, Sleep Deprivation
- Being tested
- Sleep deprivation, Normal sleep
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationOther
Also called Sleep and muscle recovery
This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and than will keep awake for 60 hours (2 nights), followed by 1 night of sleep, all inside the lab. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain.
Normal sleepOther
This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and and will be able to sleep the 3 nights. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain.
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Exercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound). Receives: Other: Sleep deprivation |
| Normal sleep | Experimental | Exercise induced-muscle damage protocol followed by 3 nights of normal sleep Receives: Other: Normal sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in isometric strength
Measured: Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage
Secondary outcomes (1)
Area Under Curve for serum total and free testosterone, IGF-1, and cortisol
Measured: Blood samples will be collected every 2 hours, for 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Hanna Karen Moreira Antunes, Federal University of São Paulo
- Investigators
- Marco Tulio Mello, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082600
- Sponsor's protocol ID
- 2010070050
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage
- ClinicalTrials.gov ID
- NCT02082600
- Acronym / sponsor ID
- 2010070050
- Conditions
- Sleep, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in which subjects will perform the exercise protocol (~18:00-19:00) and will be subject to normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep rebound.
Detailed description
The blood parameters analyzed will be:
- Creatine kinase and myoglobin: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol.
- Total and free testosterone, IGF-1, and cortisol: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. Moreover, from 19:00 of the second day to 19:00 of the third day it will be collected blood samples every 2 hours.
- GH: during the second night, GH will be evaluated every 1 hour, from 23:00 to 07:00.
- TNF-alfa, IL-6, IL-1 beta, IL-10, and IL-1ra: before, immediately after, and 2 hour after exercise, as well every 4 hours from 19:00 of the second day to 19:00 of the third day.
It will be evaluated isometric strength every 12 hours, as well visual analog scale of pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Other: Sleep deprivationExercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound). |
| Normal sleep | Experimental | Other: Normal sleepExercise induced-muscle damage protocol followed by 3 nights of normal sleep |
Who may qualify
- Ages
- 20 to 31 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy subjects
- sedentary
- sleep duration between 6-8 hours peer night
Key exclusion criteria (12 listed)
- smokers
- use vitamin supplements, like C and E
- drink two doses of alcohol/day or > 4 doses in one occasion
- use of anti-inflammatory drugs
- antilipidemic drugs
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 |
|---|---|---|
| Sleep deprivationAlso: Sleep and muscle recoveryThis group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and than will keep awake for 60 hours (2 nights), followed by 1 night of sleep, all inside the lab. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain. | Other | Sleep deprivation |
| Normal sleepThis group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and and will be able to sleep the 3 nights. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain. | Other | Normal sleep |
Primary outcome
Change from baseline in isometric strength
Time frame: Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage
1 secondary outcome
Area Under Curve for serum total and free testosterone, IGF-1, and cortisol
Time frame: Blood samples will be collected every 2 hours, for 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Marco Tulio Mello, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation and Normal sleep in people with Sleep and Sleep Deprivation, run by Federal University of São Paulo 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Mar 2014. 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. 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?
Results are not available in the source record.
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?
Change from baseline in isometric strength (time frame: Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage). 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 11 Mar 2014.