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
Recruitment status was Recruiting
Sponsor:
Assaf-Harofeh Medical Center
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 3, 2009 | ||||||||
| Last Updated Date | May 4, 2009 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
apnea hypopnea index after sildenafil vs. placebo [ Time Frame: Hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00893191 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo [ Time Frame: hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction | ||||||||
| Official Title ICMJE | The Effect of Sildenafil on Sleep-Disordered Breathing in Obese Patients With Sexual Dysfunction | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 50 healthy males aged 40 - 65 years |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 40 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00893191 | ||||||||
| Other Study ID Numbers ICMJE | 39/09 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Isaac Shpirer, Asaf Harofeh Medical Center | ||||||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Assaf-Harofeh Medical Center | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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