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Completed

NCT Number: NCT01884454

SLEEP AND OSA 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04024002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep deprivation

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: PSAR01

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 24, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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