The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

NCT ID: NCT03086122

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-04-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obstructive Sleep Apnea (OSA)

OSA patients without erectile dysfunction (ED).

Group Type: NO_INTERVENTION

No interventions assigned to this group

OSA + ED

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

OSA + ED + CPAP

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

Group Type: EXPERIMENTAL

Continuous positive airway pressure

Intervention Type: DEVICE

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

Interventions

Continuous positive airway pressure

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

Intervention Type: DEVICE

Other Intervention Names

CPAP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Ferran Barbe

Head of Respiratory Medicine at Hospital Universitari Arnau de Vilanova

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbé, MD

Role: PRINCIPAL_INVESTIGATOR

Spanish Respiratory Society

Locations

Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Lleida, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30089160 (View on PubMed)

Other Identifiers

Nº80-Separ2011

Identifier Type: -

Identifier Source: org_study_id