NCT00893191

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

First QC Date

May 3, 2009

Last Update Submit

May 4, 2009

Conditions

SildenafilSleep ApneaSexual DysfunctionObesity

Outcome Measures

Primary Outcomes (1)

  • apnea hypopnea index after sildenafil vs. placebo

    Hours

Secondary Outcomes (1)

  • Sleep parameters (latency, efficiency etc) following sildenafil vs. placebo

    hours

Study Arms (2)

Sildenafil

Treated with 50 mg of Sildenafil at night

Placebo

Treated with placebo at night

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 healthy males aged 40 - 65 years

You may qualify if:

  • Age - 40-65 years
  • BMI equal to or over 30

You may not qualify if:

  • A known cardiorespiratory, liver or kidney disease
  • Treatment with nitrates or alfa blockers
  • Performed polysomnography in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesSexual Dysfunction, PhysiologicalObesity

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGenital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Isaac Shpiree, MD

CONTACT

972-8-9779024I_shpirer@yahoo.com

Arnon Elizur, MD

CONTACT

972-8-9779817elizura@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 3, 2009

First Posted

May 5, 2009

Study Start

May 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

IL(1)