Effects of Nightshift Work and Sleep Disturbances on Erectile Function

January 12, 2021 updated by: gokhan calik, Istanbul Medipol University Hospital

Effects of Nightshift Work and Sleep Disturbances on Erectile Function, Serum Testosterone Levels, Nocturia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sisli
      • Istanbul, Sisli, Turkey
        • Recruiting
        • Cemil Tascioglu Cith Hospital
        • Contact:
    • İstanbul
      • Bağcılar, İstanbul, Turkey
        • Recruiting
        • Istanbul Medipol University Hospital
        • Contact:
        • Principal Investigator:
          • Gokhan Calik, Asst.Prof.
        • Principal Investigator:
          • Vahit Guzelburc, Asst.Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nightshift workers
Diagnostic test: IIEF-5
IIEF-15 form will be filled out by all participants
Non-nightshift workers
Diagnostic test: IIEF-5
IIEF-15 form will be filled out by all participants

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Collaborators

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2020

Primary Completion (ANTICIPATED)

May 20, 2021

Study Completion (ANTICIPATED)

November 20, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedipolUrology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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