Effects of Sleep Deprivation on Blood Hormones and Inflam... | NCT02082600

Studies
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage

NCT02082600

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Mar 11, 2014Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Sleep
Sleep Deprivation

Interventions

Sleep deprivation
Normal sleep

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Mar 6, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2014

Last Update Posted Date

Mar 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanna Karen Moreira Antunes, PhD, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep deprivation	Experimental	Exercise induced-muscle damage protocol followed by 60h of sleep deprivation (two nights) and one night of normal sleep (rebound).	Other: Sleep deprivation
Normal sleep	Experimental	Exercise induced-muscle damage protocol followed by 3 nights of normal sleep	Other: Normal sleep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep deprivation	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in isometric strength		Before exercise, immediatly after, 12, 24, 36, 48, and 60 hours after exercise induced-muscle damage

Secondary Outcomes

Measure	Description	Time Frame
Area Under Curve for serum total and free testosterone, IGF-1, and cortisol		Blood samples will be collected every 2 hours, for 24 hours.

Other Outcomes

Measure	Description	Time Frame
Area Under Curve for serum pro and anti-inflammatory cytokines		Blood samples will be collected every 4 hours, for 24 hours.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects
sedentary
sleep duration between 6-8 hours peer night

Exclusion Criteria:

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
muscle or joint diseases
cardiovascular diseases
diabetes
renal diseases
sleep disturbances
breathing disorders

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

31 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Tulio Mello, PhD	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Associação Fundo de Incentivo à Pesquisa		São Paulo	São Paulo	04020-050	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012892	Sleep Deprivation

Ancestor Terms

ID	Term
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012890	Sleep

Ancestor Terms

ID	Term
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided