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The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Erectile Dysfunction, CPAP treatment, Endothelial Dysfunction, Cardiovascular risk

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Obstructive Sleep Apnea (OSA)

OSA + ED

OSA + ED + CPAP

Arm Description

OSA patients without erectile dysfunction (ED).

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Self-Esteem And Relationship (SEAR) score
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, using SEAR score. Evaluate the impact of CPAP treatment on the change in SEAR score after 3 months.
Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
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. Evaluate the impact of CPAP treatment on the change in the sexual hormone profile after 3 months. All hormones measured in blood samples by means of Radioimmunoassay.
Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
Determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder associated to obstructive sleep apnea and its relation to the risk of developing erectile dysfunction. Evaluate the impact of CPAP treatment on the changes in endothelial dysfunction biomarkers after 3 months. All markers measured in blood samples by means of Radioimmunoassay.

Full Information

First Posted
March 12, 2017
Last Updated
April 5, 2019
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT03086122
Brief Title
The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
Official Title
The Impact of Obstructive Sleep Apnea in Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Erectile Dysfunction, CPAP treatment, Endothelial Dysfunction, Cardiovascular risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obstructive Sleep Apnea (OSA)
Arm Type
No Intervention
Arm Description
OSA patients without erectile dysfunction (ED).
Arm Title
OSA + ED
Arm Type
No Intervention
Arm Description
OSA patients with erectile dysfunction diagnosis who are randomly allocated to not receive continuous positive airway pressure (CPAP).
Arm Title
OSA + ED + CPAP
Arm Type
Experimental
Arm Description
OSA patients with erectile dysfunction diagnosis who are randomly allocated to receive CPAP.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.
Primary Outcome Measure Information:
Title
Change in International Index Erectile Function (IIEF) score
Description
Effect of 3-months CPAP treatment on the changes in the International Index Erectile Function score of patients with Erectile Dysfunction.
Time Frame
At baseline and 3 month
Secondary Outcome Measure Information:
Title
Change in Self-Esteem And Relationship (SEAR) score
Description
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, using SEAR score. Evaluate the impact of CPAP treatment on the change in SEAR score after 3 months.
Time Frame
At baseline and 3 month
Title
Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
Description
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. Evaluate the impact of CPAP treatment on the change in the sexual hormone profile after 3 months. All hormones measured in blood samples by means of Radioimmunoassay.
Time Frame
At baseline and 3 month
Title
Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
Description
Determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder associated to obstructive sleep apnea and its relation to the risk of developing erectile dysfunction. Evaluate the impact of CPAP treatment on the changes in endothelial dysfunction biomarkers after 3 months. All markers measured in blood samples by means of Radioimmunoassay.
Time Frame
At baseline and 3 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Barbé, MD
Organizational Affiliation
Spanish Respiratory Society
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau de Vilanova. IRB Lleida. CIBERes
City
Lleida
ZIP/Postal Code
25198
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30089160
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.
Results Reference
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The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

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