Obstructive Sleep ApneaNCT03086122
The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of "obstructive sleep apnea syndrome" (Apnea-Hypopnea Index >10)
- Diagnosis of erectile dysfunction (International Index of Erectile Function score <25)
- Signed informed consent
Who cannot join
- Psycho-physical inability to perform or collaborate with performing tests.
- Patients presenting any of the following conditions:
- cardiovascular diseases, neurological diseases (multiple sclerosis, Parkinson's disease, spinal disc disease).
- history of pelvic or retroperitoneal surgery.
- congenital or acquired malformations (Peyronie's disease, hypospadias, epispadias, penile fracture).
- hormonal disorders (hypogonadism, hyperprolactinemia, hyper or hypothyroidism, Cushing's disease).
- drug addiction and/or alcoholics and treatment with any of the following drugs: antidepressants, antipsychotics.
Trial locations and contacts
1 site in 1 country.
About this study
The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms that are altered as a result of the events associated with obstructive sleep apnea (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are epidemiological studies.
The alterations in the expression profile of endothelial and cardiovascular dysfunction biomarkers and sex hormones disorders that are altered as a result of the events associated with OSA are associated to erectile dysfunction development.
Read more
Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and patients with erectile dysfunction may improve erectile function.
The primary objective of the study is:
- To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.
The secondary objectives are:
- To determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder, which are altered as a result of the syndrome of obstructive sleep apnea and its relation to the risk of developing erectile dysfunction.
- To compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction.
- To assess the prevalence of erectile dysfunction in patients with OSA.
- To compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction.
- To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients.
- To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous positive airway pressure
- Keywords
- OSA, Erectile Dysfunction, CPAP treatment, Endothelial Dysfunction, Cardiovascular risk
- Medical subject headings
- Sleep Apnea, Obstructive, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | No intervention | OSA patients without erectile dysfunction (ED). |
| OSA + ED | No intervention | OSA patients with erectile dysfunction diagnosis who are randomly allocated to not receive continuous positive airway pressure (CPAP). |
| OSA + ED + CPAP | Experimental | OSA patients with erectile dysfunction diagnosis who are randomly allocated to receive CPAP. Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Index Erectile Function (IIEF) score
Effect of 3-months CPAP treatment on the changes in the International Index Erectile Function score of patients with Erectile Dysfunction.
Measured: At baseline and 3 month
Secondary outcomes (3)
Change in Self-Esteem And Relationship (SEAR) score
Compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction, using SEAR score. Evaluate the impact of CPAP treatment on the change in SEAR score after 3 months.
Measured: At baseline and 3 month
Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
Compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction. Evaluate the impact of CPAP treatment on the change in the sexual hormone profile after 3 months. All hormones measured in blood samples by means of Radioimmunoassay.
Measured: At baseline and 3 month
Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
Determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder associated to obstructive sleep apnea and its relation to the risk of developing erectile dysfunction. Evaluate the impact of CPAP treatment on the changes in endothelial dysfunction biomarkers after 3 months. All markers measured in blood samples by means of Radioimmunoassay.
Measured: At baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startApr 2013
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbé, MD, Principal investigator, Spanish Respiratory Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086122
- Sponsor's protocol ID
- Nº80-Separ2011
- Status last verified
- Apr 2019
- First submitted
- 12 Mar 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pascual M, de Batlle J, Barbe F, Castro-Grattoni AL, Auguet JM, Pascual L, Vila M, Cortijo A, Sanchez-de-la-Torre M. Erectile dysfunction in obstructive sleep apnea patients: A randomized trial on the effects of Continuous Positive Airway Pressure (CPAP). PLoS One. 2018 Aug 8;13(8):e0201930. doi: 10.1371/journal.pone.0201930. eCollection 2018.
PubMed 30089160
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03086122
- Acronym / sponsor ID
- Nº80-Separ2011
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Erectile Dysfunction, CPAP treatment, Endothelial Dysfunction, Cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Mar 2017 (actual)
- 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.
The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms that are altered as a result of the events associated with obstructive sleep apnea (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are epidemiological studies.
The alterations in the expression profile of endothelial and cardiovascular dysfunction biomarkers and sex hormones disorders that are altered as a result of the events associated with OSA are associated to erectile dysfunction development.
Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and patients with erectile dysfunction may improve erectile function.
The primary objective of the study is:
- To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.
The secondary objectives are:
- To determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder, which are altered as a result of the syndrome of obstructive sleep apnea and its relation to the risk of developing erectile dysfunction.
- To compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction.
- To assess the prevalence of erectile dysfunction in patients with OSA.
- To compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction.
- To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients.
- To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | No intervention | –OSA patients without erectile dysfunction (ED). |
| OSA + ED | No intervention | –OSA patients with erectile dysfunction diagnosis who are randomly allocated to not receive continuous positive airway pressure (CPAP). |
| OSA + ED + CPAP | Experimental | Device: Continuous positive airway pressureOSA patients with erectile dysfunction diagnosis who are randomly allocated to receive CPAP. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of "obstructive sleep apnea syndrome" (Apnea-Hypopnea Index >10)
- Diagnosis of erectile dysfunction (International Index of Erectile Function score <25)
- Signed informed consent
Key exclusion criteria (7 listed)
- Psycho-physical inability to perform or collaborate with performing tests.
- Patients presenting any of the following conditions:
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 |
|---|---|---|
| Continuous positive airway pressureAlso: CPAPContinuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months. | Device | OSA + ED + CPAP |
Primary outcome
Change in International Index Erectile Function (IIEF) score
Time frame: At baseline and 3 month
Effect of 3-months CPAP treatment on the changes in the International Index Erectile Function score of patients with Erectile Dysfunction.
3 secondary outcomes
Change in Self-Esteem And Relationship (SEAR) score
Time frame: At baseline and 3 month
Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
Time frame: At baseline and 3 month
Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
Time frame: At baseline and 3 month
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 8 Apr 2019.
- Derived from this study: PubMed 30089160Pascual M, de Batlle J, Barbe F, Castro-Grattoni AL, Auguet JM, Pascual L, Vila M, Cortijo A, Sanchez-de-la-Torre M. Erectile dysfunction in obstructive sleep apnea patients: A randomized trial on the effects of Continuous Positive Airway Pressure (CPAP). PLoS One. 2018 Aug 8;13(8):e0201930. doi: 10.1371/journal.pone.0201930. eCollection 2018.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
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Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
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RecruitingObservational study
Development of a Multimodal Deep Learning Model for Pediatric Patients
Pediatric Obstructive Sleep Apnea, Polysomnography
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.
Ferran Barbé, MD principal investigator
Spanish Respiratory Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 3 inclusion and 7 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 8 Apr 2019. 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 Spain. 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 International Index Erectile Function (IIEF) score (time frame: At baseline and 3 month). 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 NCT03086122, which also lists 1 linked publication.
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 8 Apr 2019.