SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN (PSAR01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Monica Levy Andersen, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01884454
First received: June 18, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Behavioral: Sleep deprivation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    - Semen collection (concentration, viability and sperm morphology)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    - Hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    - Polysomnography

  • 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 ] [ Designated as safety issue: Yes ]
    Blood will be collected in specific tubes (PaxGene)for RNA extraction and gene expression determination.


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
No Intervention: 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.
Experimental: 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
No Intervention: Control
The control group will be subjects with an apnea hypopnea index <5/h.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884454

Contacts
Contact: Monica L Andersen, Prof 55 11 21490155 ext 160 ml.andersen12@gmail.com
Contact: Tathiana A Alvarenga, PhD 55 11 21490155 ext 160 tafalvarenga@gmail.com

Locations
Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, Brazil, 04024002
Contact: Tathiana A Alvarenga, PhD    55 11 21490155 ext 160    tafalvarenga@gmail.com   
Contact: Monica L Andersen, Prof    55 11 21490155 ext 160    ml.andersen12@gmail.com   
Principal Investigator: Tathiana A Alvarenga, PhD         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Monica Levy Andersen, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01884454     History of Changes
Other Study ID Numbers: PSAR01
Study First Received: June 18, 2013
Last Updated: June 20, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
sleep
obstructive sleep apnea
reproduction
sperm
hormones
men

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014