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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Assaf-Harofeh Medical Center Identifier:
First received: May 3, 2009
Last updated: May 4, 2009
Last verified: May 2009
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.

Sleep Apnea
Sexual Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

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

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

Estimated Enrollment: 50
Study Start Date: May 2009
Treated with 50 mg of Sildenafil at night
Treated with placebo at night


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

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
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Please refer to this study by its identifier: NCT00893191

Contact: Isaac Shpiree, MD 972-8-9779024
Contact: Arnon Elizur, MD 972-8-9779817

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 Identifier: NCT00893191     History of Changes
Other Study ID Numbers: 39/09
Study First Received: May 3, 2009
Last Updated: May 4, 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 processed this record on May 23, 2017