Effects of Nightshift Work and Sleep Disturbances on Erectile Function

NCT04707807 | Unknown

• 1 other identifier: MedipolUrology
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Erectile dysfunction

  Decreased scores of IIEF-5

  3-6 months

Study Arms (2)

Nightshift workers

Diagnostic Test: IIEF-5

Non-nightshift workers

Diagnostic Test: IIEF-5

Interventions

IIEF-5 DIAGNOSTIC_TEST

IIEF-15 form will be filled out by all participants

Nightshift workers; Non-nightshift workers

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Suffering from erectile dysfunction
• Mainly psychogenic ED
• Employed

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (2)

Istanbul Medipol University Hospital

Bağcılar, Istanbul, Turkey (Türkiye)

RECRUITING

Cemil Tascioglu Cith Hospital

Istanbul, Sisli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Nocturia; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Gokhan Calik, Asst.Prof.

CONTACT

+905362666604; gcalik@medipol.edu.tr

Vahit Guzelburc, Asst.Prof.

CONTACT

+905322856674; vguzelburc@medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 13, 2021
• Study Start: November 20, 2020
• Primary Completion: May 20, 2021
• Study Completion: November 20, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)