The Effect of Sildenafil on Sleep-Disordered Breathing in... | NCT00893191

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

NCT00893191

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

May 5, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Sildenafil
Sleep Apnea
Sexual Dysfunction
Obesity

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 3, 2009

First Submission Date that Met QC Criteria

May 4, 2009

First Posted Date

May 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2009

Last Update Posted Date

May 5, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sildenafil		Treated with 50 mg of Sildenafil at night
Placebo		Treated with placebo at night

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

50 healthy males aged 40 - 65 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isaac Shpiree, MD	Contact	972-8-9779024		I_shpirer@yahoo.com
Arnon Elizur, MD	Contact	972-8-9779817		elizura@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asaf Harofeh Medical Center	Recruiting	Ẕerifin		70300	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D012735	Sexual Dysfunction, Physiological
D009765	Obesity

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided