Obesity Clinical Trial
Official title:
The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction
| NCT number | NCT00893191 |
| Other study ID # | 39/09 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | May 3, 2009 |
| Last updated | May 4, 2009 |
| Start date | 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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 40 Years to 65 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Asaf Harofeh Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | apnea hypopnea index after sildenafil vs. placebo | Hours | Yes | |
| Secondary | Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo | hours | Yes |
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