Clinical trial NCT03086122: The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
Official title: The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Erectile Dysfunction
CPAP treatment
Endothelial Dysfunction
Cardiovascular risk
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in International Index Erectile Function (IIEF) score
timeFrame: At baseline and 3 month
Secondary outcomes:
measure: Change in Self-Esteem And Relationship (SEAR) score
timeFrame: At baseline and 3 month
measure: Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
timeFrame: At baseline and 3 month
measure: Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
timeFrame: At baseline and 3 month
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova. IRB Lleida. CIBERes
Study officials:
affiliation: Spanish Respiratory Society
name: Ferran Barbé, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.