The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

NCT03086122 | Completed

• 1 other identifier: Nº80-Separ2011
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Keywords

OSA; Erectile Dysfunction; CPAP treatment; Endothelial Dysfunction; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Change in International Index Erectile Function (IIEF) score

  Effect of 3-months CPAP treatment on the changes in the International Index Erectile Function score of patients with Erectile Dysfunction.

  At baseline and 3 month

Secondary Outcomes (3)

• Change in Self-Esteem And Relationship (SEAR) score

  At baseline and 3 month

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

  At baseline and 3 month

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

  At baseline and 3 month

Study Arms (3)

Obstructive Sleep Apnea (OSA)

NO INTERVENTION

OSA patients without erectile dysfunction (ED).

OSA + ED

NO INTERVENTION

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

OSA + ED + CPAP

EXPERIMENTAL

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

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure DEVICE

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

Also known as: CPAP

OSA + ED + CPAP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Lleida, 25198, Spain

Location

Related Publications (1)

• 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.

  PMID: 30089160 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Erectile Dysfunction

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ferran Barbé, MD

  Spanish Respiratory Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory Medicine at Hospital Universitari Arnau de Vilanova

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)