Sleep Apnea, ObstructiveNCT00832065
Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome
An observational study of Sleep Apnea, Obstructive and Sleep Apnea, run by Lahey Clinic at 2 sites in United States.
Trial summary
Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Apnea, Hypotestosteronism
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Aug 2016
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic
Who may be able to join
- Adult males ages 18-70 with newly diagnosed OSAS documented by all-night polysomnography (PSG)
Who cannot join
- Currently on testosterone replacement therapy
- Prior known cause of erectile dysfunction
- Patients with prior treatment of erectile dysfunction
- Co-morbid conditions like diabetes, hypertension, as well as patient medications, will be recorded, and will not be part of the exclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
Lahey Clinic Northshore
Peabody, Massachusetts, 01960
About this study
Official title: Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy
Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments.
Read the detailed description
Obstructive Sleep Apnea Syndrome(OSAS) is a highly prevalent disease in the population, affecting at least 4% of males and to a lesser extent females, yet it is currently under diagnosed. OSAS is associated with various disorders including cardiovascular disease, insulin resistance, diabetes mellitus, fatigue and erectile dysfunction. Currently the standard treatment for OSAS is Continuous Positive Airway Pressure(CPAP).
Low testosterone levels are present in some patients with OSAS leading to erectile dysfunction. However, the true prevalence of low testosterone levels and its correlation with sexual health is poorly understood and undefined. Prior data suggest treating these patients with CPAP therapy, usually increases testosterone levels, but unclear if this makes any meaningful difference in patient outcome, that is improvement in libido and sexual function.
There are several postulations to the pathophysiology of low testosterone levels in patients with OSAS. CRP(C-reactive protein), a strong marker of inflammation was shown to be elevated in patients with OSAS. The association between elevated CRP and low testosterone level would support the notion that inflammation plays a primary role in sexual dysfunction in patients with OSAS.
The objective of this study is to identify correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Evaluate the role of CRP and inflammation secondary to OSAS in the pathogenesis of sexual dysfunction.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Hypotestosteronism
- Keywords
- Sleep Apnea Syndrome, Sleep Apnea, CPAP, Low testosterone, Sexual Dysfunction
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Sleep Apnea and Low Testosterone | Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Free testosterone levels and its affect with CPAP treatment
Measured: 3 months
Secondary outcomes (1)
Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: No patients enrolled in study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akmal Sarwar, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832065
- Sponsor's protocol ID
- 2008-066
- Status last verified
- Aug 2017
- First submitted
- 28 Jan 2009
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Karacan I, Karatas M. Erectile dysfunction in sleep apnea and response to CPAP. J Sex Marital Ther. 1995 Winter;21(4):239-47. doi: 10.1080/00926239508414643.
PubMed 8789505Bratel T, Wennlund A, Carlstrom K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7. doi: 10.1016/s0954-6111(99)90068-9.
PubMed 10464840Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8. doi: 10.1210/jcem-68-2-352.
PubMed 2493027Goncalves MA, Guilleminault C, Ramos E, Palha A, Paiva T. Erectile dysfunction, obstructive sleep apnea syndrome and nasal CPAP treatment. Sleep Med. 2005 Jul;6(4):333-9. doi: 10.1016/j.sleep.2005.03.001.
PubMed 15946896Hoekema A, Stel AL, Stegenga B, van der Hoeven JH, Wijkstra PJ, van Driel MF, de Bont LG. Sexual function and obstructive sleep apnea-hypopnea: a randomized clinical trial evaluating the effects of oral-appliance and continuous positive airway pressure therapy. J Sex Med. 2007 Jul;4(4 Pt 2):1153-62. doi: 10.1111/j.1743-6109.2006.00341.x. Epub 2006 Nov 1.
PubMed 17081222Luboshitzky R, Lavie L, Shen-Orr Z, Lavie P. Pituitary-gonadal function in men with obstructive sleep apnea. The effect of continuous positive airways pressure treatment. Neuro Endocrinol Lett. 2003 Dec;24(6):463-7.
PubMed 15073577
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy
- ClinicalTrials.gov ID
- NCT00832065
- Acronym / sponsor ID
- 2008-066
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Hypotestosteronism
- Keywords
- Sleep Apnea Syndrome, Sleep Apnea, CPAP, Low testosterone, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled in study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Jan 2009 (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.
Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments.
Detailed description
Obstructive Sleep Apnea Syndrome(OSAS) is a highly prevalent disease in the population, affecting at least 4% of males and to a lesser extent females, yet it is currently under diagnosed. OSAS is associated with various disorders including cardiovascular disease, insulin resistance, diabetes mellitus, fatigue and erectile dysfunction. Currently the standard treatment for OSAS is Continuous Positive Airway Pressure(CPAP).
Low testosterone levels are present in some patients with OSAS leading to erectile dysfunction. However, the true prevalence of low testosterone levels and its correlation with sexual health is poorly understood and undefined. Prior data suggest treating these patients with CPAP therapy, usually increases testosterone levels, but unclear if this makes any meaningful difference in patient outcome, that is improvement in libido and sexual function.
There are several postulations to the pathophysiology of low testosterone levels in patients with OSAS. CRP(C-reactive protein), a strong marker of inflammation was shown to be elevated in patients with OSAS. The association between elevated CRP and low testosterone level would support the notion that inflammation plays a primary role in sexual dysfunction in patients with OSAS.
The objective of this study is to identify correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Evaluate the role of CRP and inflammation secondary to OSAS in the pathogenesis of sexual dysfunction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Sleep Apnea and Low Testosterone | – | –Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic
Key inclusion criteria (1 listed)
- Adult males ages 18-70 with newly diagnosed OSAS documented by all-night polysomnography (PSG)
Key exclusion criteria (4 listed)
- Currently on testosterone replacement therapy
- Prior known cause of erectile dysfunction
- Patients with prior treatment of erectile dysfunction
- Co-morbid conditions like diabetes, hypertension, as well as patient medications, will be recorded, and will not be part of the exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Free testosterone levels and its affect with CPAP treatment
Time frame: 3 months
1 secondary outcome
Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 8789505Karacan I, Karatas M. Erectile dysfunction in sleep apnea and response to CPAP. J Sex Marital Ther. 1995 Winter;21(4):239-47. doi: 10.1080/00926239508414643.
- Background: PubMed 10464840Bratel T, Wennlund A, Carlstrom K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7. doi: 10.1016/s0954-6111(99)90068-9.
- Background: PubMed 2493027Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8. doi: 10.1210/jcem-68-2-352.
- Background: PubMed 15946896Goncalves MA, Guilleminault C, Ramos E, Palha A, Paiva T. Erectile dysfunction, obstructive sleep apnea syndrome and nasal CPAP treatment. Sleep Med. 2005 Jul;6(4):333-9. doi: 10.1016/j.sleep.2005.03.001.
- Background: PubMed 17081222Hoekema A, Stel AL, Stegenga B, van der Hoeven JH, Wijkstra PJ, van Driel MF, de Bont LG. Sexual function and obstructive sleep apnea-hypopnea: a randomized clinical trial evaluating the effects of oral-appliance and continuous positive airway pressure therapy. J Sex Med. 2007 Jul;4(4 Pt 2):1153-62. doi: 10.1111/j.1743-6109.2006.00341.x. Epub 2006 Nov 1.
- Background: PubMed 15073577Luboshitzky R, Lavie L, Shen-Orr Z, Lavie P. Pituitary-gonadal function in men with obstructive sleep apnea. The effect of continuous positive airways pressure treatment. Neuro Endocrinol Lett. 2003 Dec;24(6):463-7.
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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.
Akmal Sarwar, M.D. principal investigator
Lahey Clinic, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Sleep Apnea, run by Lahey Clinic at 2 sites in United States.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Free testosterone levels and its affect with CPAP treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832065, which also lists 6 linked publications.
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 24 Aug 2017.