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The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00893191
Recruitment Status : Unknown
Verified May 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : May 5, 2009
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Sildenafil has been shown to aggravate sleep-disordered breathing in patients with severe obstructive sleep apnea. The aim of the present study is to examine the frequency of sleep-disordered breathing in obese patients who are candidates for treatment with sildenafil for sexual dysfunction. In addition we wish to assess the effect of sildenafil on sleep-disordered breathing.

Condition or disease
Sildenafil Sleep Apnea Sexual Dysfunction Obesity

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
Study Start Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Sildenafil
Treated with 50 mg of Sildenafil at night
Placebo
Treated with placebo at night


Outcome Measures

Primary Outcome Measures :
  1. apnea hypopnea index after sildenafil vs. placebo [ Time Frame: Hours ]

Secondary Outcome Measures :
  1. Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo [ Time Frame: hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 healthy males aged 40 - 65 years
Criteria

Inclusion Criteria:

  • Age - 40-65 years
  • BMI equal to or over 30

Exclusion Criteria:

  • A known cardiorespiratory, liver or kidney disease
  • Treatment with nitrates or alfa blockers
  • Performed polysomnography in the past
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893191


Contacts
Contact: Isaac Shpiree, MD 972-8-9779024 I_shpirer@yahoo.com
Contact: Arnon Elizur, MD 972-8-9779817 elizura@gmail.com

Locations
Israel
Asaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Principal Investigator: Isaac Shpirer, MD         
Sub-Investigator: Yoram I Siegel, MD         
Sub-Investigator: Arnon Elizur, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information

Responsible Party: Isaac Shpirer, Asaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00893191     History of Changes
Other Study ID Numbers: 39/09
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents