The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

Sociedad Española de Neumología y Cirugía Torácica

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Continuous positive airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03086122

Nº80-Separ2011

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Obstructive Sleep Apnea (OSA)

No Intervention group

Description:

OSA patients without erectile dysfunction (ED).

OSA + ED

No Intervention group

Description:

OSA patients with erectile dysfunction diagnosis who are randomly allocated to not receive continuous positive airway pressure (CPAP).

OSA + ED + CPAP

Experimental group

Description:

OSA patients with erectile dysfunction diagnosis who are randomly allocated to receive CPAP.

Treatment:

Device: Continuous positive airway pressure