SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN (PSAR01)

February 2, 2016 updated by: Monica Levy Andersen, Federal University of São Paulo

EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study will be recruited volunteers 25-50 years of age with a body mass index (BMI) 20-25 kg/m2 (normal) that after performing polysomnography, will be distributed in the following groups: healthy or diagnosed with obstructive sleep apnea syndrome (OSA). Volunteers without OSA 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). Blood samples will be taken for hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)and gene expression. The semen collection for evaluation of sperm count (concentration, viability and sperm morphology) in three different periods, baseline collection, after SD protocols and the end of rebound period. Individuals diagnosed with OSA also have three collections of blood and semen samples for analyzes.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04024002
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-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

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total sleep deprivation
Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours.
Behavioral: Sleep deprivation
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).
Other Names:
  • Total sleep deprivation
  • REM 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
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).
Other Names:
  • Total sleep deprivation
  • REM sleep deprivation
Control
The control group will be subjects with an apnea hypopnea index <5/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sperm analysis
Time Frame: change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
- 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change hormonal evaluation
Time Frame: change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
- Hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep patterns of the study population
Time Frame: Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
- Polysomnography
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
Time Frame: Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
Blood will be collected in specific tubes (PaxGene)for RNA extraction and gene expression determination.
Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Tathiana A Alvarenga, PhD, Federal University of São Paulo
  • Study Director: Monica L Andersen, Prof, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSAR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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