Erectile Dysfunction in Severe Obstructive Sleep Apnea: E... | NCT01600066

Studies
Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy

NCT01600066

Sponsor

University of Giessen

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea
Erectile Dysfunction

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
UGLC	Other Identifier	UGLC

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 9, 2012

First Submission Date that Met QC Criteria

May 14, 2012

First Posted Date

May 16, 2012Estimated

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

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may reverse erectile dysfunction in affected patients. The present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.

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

Retention

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of erectile function in severe sleep apnea after 6-12 months of CPAP therapy	an established self-administered questionnaire is used to assess changes in erectile function occurring after 6-12 months of CPAP therapy in patients with severe sleep apnea	at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

apnea-hypopnea-index > 30/h
no CPAP therapy
male gender
18-80 years of age
having or attempting to have regular sexual intercourse

Exclusion Criteria:

apnea-hypopnea-index < 30/h
already treated by CPAP
female gender
age < 18 or > 80 years
not having or not attempting to have regular sexual intercourse

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

male patients with untreated severe sleep apnea (apnea-hypopnea-index > 30/h)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Schulz, MD	University of Giessen Lung Center, Germany	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided