The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Erectile Dysfunction
Study type: Interventional

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.
    


Intervention name(s): Continuous positive airway pressure
Intervention type(s): Device
Intervention description(s): Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; Erectile Dysfunction; CPAP treatment; Endothelial Dysfunction; Cardiovascular risk