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NCT Number: NCT03086122

The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

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:

1. 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. 2. 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. 3. To assess the prevalence of erectile dysfunction in patients with OSA. 4. 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. 5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients. 6. To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Lleida, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of "obstructive sleep apnea syndrome" (Apnea-Hypopnea Index >10)
  • Diagnosis of erectile dysfunction (International Index of Erectile Function score <25)
  • Signed informed consent

Exclusion criteria

  • 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.

Treatment and study plan

Continuous Positive Airway Pressure

Device

Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.

Other names: CPAP

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Self-Esteem And Relationship (SEAR) score

    Time frame: At baseline and 3 month

    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.

  2. Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)

    Time frame: At baseline and 3 month

    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.

  3. Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)

    Time frame: At baseline and 3 month

    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.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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