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

The recruitment status of this study is unknown because the information has not been verified recently.
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 ] [ Designated as safety issue: Yes ]

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

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
Genders 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
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Sildenafil Citrate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents processed this record on May 26, 2016