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
  Purpose

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.


Condition
Sildenafil
Sleep Apnea
Sexual Dysfunction
Obesity

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
Groups/Cohorts
Sildenafil
Treated with 50 mg of Sildenafil at night
Placebo
Treated with placebo at night

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893191

Contacts
Contact: Isaac Shpiree, MD 972-8-9779024 I_shpirer@yahoo.com
Contact: Arnon Elizur, MD 972-8-9779817 elizura@gmail.com

Locations
Israel
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

No publications provided

Responsible Party: Isaac Shpirer, Asaf Harofeh Medical Center
ClinicalTrials.gov 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:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on October 19, 2014