Obstructive Sleep ApneaPSAR01NCT01884454
SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN
An observational study of Obstructive Sleep Apnea, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep deprivation
- Keywords
- sleep, obstructive sleep apnea, reproduction, sperm, hormones, men
- Medical subject headings
- Sleep Apnea, Obstructive, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
Also called Total sleep deprivation, REM 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).
| Study group | Role | What they receive |
|---|---|---|
| Total sleep deprivation | Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours. Receives: 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. Receives: Behavioral: Sleep deprivation | |
| Control | The control group will be subjects with an apnea hypopnea index <5/h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sperm analysis
- Semen collection (concentration, viability and sperm morphology)
Measured: 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
- Hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)
Measured: change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Levy Andersen, Federal University of São Paulo
- Investigators
- Tathiana A Alvarenga, PhD, Principal investigator, Federal University of São PauloMonica L Andersen, Prof, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884454
- Sponsor's protocol ID
- PSAR01
- Acronym
- PSAR01
- Status last verified
- Feb 2016
- First submitted
- 18 Jun 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN
- ClinicalTrials.gov ID
- NCT01884454
- Acronym / sponsor ID
- PSAR01 / PSAR01
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep, obstructive sleep apnea, reproduction, sperm, hormones, men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total sleep deprivation | – | Behavioral: Sleep deprivationHealthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours. |
| 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 | – | Behavioral: Sleep deprivationHealthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours. |
| Control | – | –The control group will be subjects with an apnea hypopnea index <5/h. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivationAlso: Total sleep deprivation, REM sleep deprivationVolunteers 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). | Behavioural | REM sleep deprivation, Total sleep deprivation |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- American Academy of Sleep MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tathiana A Alvarenga, PhD principal investigator
Federal University of São Paulo
Monica L Andersen, Prof study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016; AzTrials last refreshed its copy on 27 Oct 2026.