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
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00893191
First received: May 3, 2009
Last updated: May 4, 2009
Last verified: May 2009

May 3, 2009
May 4, 2009
May 2009
Not Provided
apnea hypopnea index after sildenafil vs. placebo [ Time Frame: Hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo [ Time Frame: hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
50 healthy males aged 40 - 65 years
  • Sildenafil
  • Sleep Apnea
  • Sexual Dysfunction
  • Obesity
Not Provided
  • Sildenafil
    Treated with 50 mg of Sildenafil at night
  • Placebo
    Treated with placebo at night
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
Not Provided

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
Male
40 Years to 65 Years   (Adult)
No
Contact: Isaac Shpiree, MD 972-8-9779024 I_shpirer@yahoo.com
Contact: Arnon Elizur, MD 972-8-9779817 elizura@gmail.com
Israel
 
NCT00893191
39/09
Not Provided
Not Provided
Not Provided
Isaac Shpirer, Asaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Not Provided
Assaf-Harofeh Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP