Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
1. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.
The secondary objectives are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 3 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Psycho-physical inability to perform or collaborate with performing tests.
Patients presenting any of the following conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ferran Barbé, MD | Spanish Respiratory Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arnau de Vilanova. IRB Lleida. CIBERes | Lleida | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089160 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | At baseline and 3 month |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D012138 |
| Respiratory Therapy |