Effects of Nightshift Work and Sleep Disturbances on Erec... | NCT04707807

Studies
Effects of Nightshift Work and Sleep Disturbances on Erectile Function

NCT04707807

Sponsor

Istanbul Medipol University Hospital

Status

Unknown status

Last Update Posted

Jan 13, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea

Interventions

IIEF-5

Countries

Turkey (Türkiye)

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

Jan 2021

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

Nov 20, 2020Actual

Primary Completion Date

May 20, 2021Estimated

Completion Date

Nov 20, 2021Estimated

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 13, 2021Actual

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

Jan 12, 2021

Last Update Posted Date

Jan 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

gokhan calik, Assistant professor, Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Name	Class
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

We aim to observe the unwanted effects of nightshift work and short term insomnia on erectile function of men aged between 25 to 60 years. We will also compare the levels of serum testosterone in the target group and compare it with the ones who don't work in hightshifts.

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

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nightshift workers			Diagnostic Test: IIEF-5
Non-nightshift workers			Diagnostic Test: IIEF-5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IIEF-5	Diagnostic Test	IIEF-15 form will be filled out by all participants	Nightshift workers Non-nightshift workers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Erectile dysfunction	Decreased scores of IIEF-5	3-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suffering from erectile dysfunction
Mainly psychogenic ED
Employed

Exclusion Criteria:

Patients with major organic causes erectile dysfunction (Radical pelvic surgery/radiation therapy, uncontrolled diabetis mellitus, uncontrolled hypertension, New York Heart Association Class 3-4 heart failure, acute coronary syndrome within 3 months, dyslipidemia)
NEET(Not in employment, education, training) patients

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

We aim to enroll mainly working class men in our study. So we are going to be able to compare the erectile function status daytime workers with nightshifters. Unemployed, retired and students will be excluded form the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gokhan Calik, Asst.Prof.	Contact	+905362666604		gcalik@medipol.edu.tr
Vahit Guzelburc, Asst.Prof.	Contact	+905322856674		vguzelburc@medipol.edu.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medipol University Hospital	Recruiting	Bağcılar	Istanbul		Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction
D053158	Nocturia
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided