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

May 4, 2009 updated by: Assaf-Harofeh Medical Center
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Asaf Harofeh Medical Center
        • Principal Investigator:
          • Isaac Shpirer, MD
        • Sub-Investigator:
          • Yoram I Siegel, MD
        • Sub-Investigator:
          • Arnon Elizur, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

50 healthy males aged 40 - 65 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Sildenafil
Treated with 50 mg of Sildenafil at night
Placebo
Treated with placebo at night

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
apnea hypopnea index after sildenafil vs. placebo
Time Frame: Hours
Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo
Time Frame: hours
hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Registration Dates

First Submitted

May 3, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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