Effects of Nightshift Work and Sleep Disturbances on Erectile Function

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: Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: IIEF-5

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • Istanbul, Sisli, Turkey
      • Recruiting
      • Cemil Tascioglu Cith Hospital
      • Contact: Alper Otunctemur, Assoc.Prof.; Phone Number: +90 5325423686; Email: alperotunctemur@yahoo.com
  • İstanbul
    • Bağcılar, İstanbul, Turkey
      • Recruiting
      • Istanbul Medipol University Hospital
      • Contact: Gokhan Calik, Asst.Prof.; Phone Number: +90 5362666604; Email: gcalik@medipol.edu.tr
      • Principal Investigator: Gokhan Calik, Asst.Prof.
      • Principal Investigator: Vahit Guzelburc, Asst.Prof.

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Decreased scores of IIEF-5	3-6 months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Collaborators: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

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: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Sleep Apnea Syndromes; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Sleep Apnea, Obstructive; Dyssomnias; Parasomnias; Erectile Dysfunction; Nocturia
• 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