NCT01884454

Brief Summary

In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea syndrome (OSA), and the importance of maintaining these hormones in reproductive processes. The present study aims to evaluate the effects of the OSA or sleep deprivation (total or selective REM sleep for 48h) on reproductive function in adult men with normal body mass index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

June 18, 2013

Last Update Submit

February 2, 2016

Conditions

Obstructive Sleep Apnea

Keywords

sleepobstructive sleep apneareproductionspermhormonesmen

Outcome Measures

Primary Outcomes (1)

  • Change in sperm analysis

    \- Semen collection (concentration, viability and sperm morphology)

    change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days

Secondary Outcomes (1)

  • change hormonal evaluation

    change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days

Other Outcomes (2)

  • Sleep patterns of the study population

    Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days

  • Change gene expression

    Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days

Study Arms (4)

Total sleep deprivation

Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours.

Behavioral: Sleep deprivation

moderate to severe OSA

Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSA) with normal or overweight body mass index (BMI), will be recruited.

REM sleep deprivation

Healthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours.

Behavioral: Sleep deprivation

Control

The control group will be subjects with an apnea hypopnea index \<5/h.

Interventions

Sleep deprivationBEHAVIORAL

Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).

Also known as: Total sleep deprivation, REM sleep deprivation
REM sleep deprivationTotal sleep deprivation

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * men * There is no discrimination of economic class * Age between 25 and 50 * BMI 30 kg/m2 * No prior neurological, psychiatric or use of psychotropic medication * OSA (moderate and severe apnea hypopnea index \> 15) Exclusion Criteria: * smokers * addiction * Individuals with another sleep disorder

You may qualify if:

  • men
  • There is no discrimination of economic class
  • Age between 25 and 50
  • BMI 30 kg/m2
  • No prior neurological, psychiatric or use of psychotropic medication
  • OSA (moderate and severe apnea hypopnea index \> 15)

You may not qualify if:

  • smokers
  • addiction
  • Individuals with another sleep disorder
  • Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus, male reproductive system
  • Presence of moderate or severe depression and psychiatric disorders
  • Volunteers with previous treatment for OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Tathiana A Alvarenga, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Monica L Andersen, Prof

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 24, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

September 1, 2014

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

BR(1)