Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep ApneaNCT04707807
Effects of Nightshift Work and Sleep Disturbances on Erectile Function
An observational study of Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea
- What is being tested?
- IIEF-5
- How many people
- 300 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2020to 20 Nov 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- 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.
Who may be able to join
- Suffering from erectile dysfunction
- Mainly psychogenic ED
- Employed
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul Medipol University Hospital
Bağcılar, Istanbul
Gokhan Calik, Asst.Prof., 5362666604 ext. +90, gcalik@medipol.edu.tr
Gokhan Calik, Asst.Prof.
- Recruiting
Cemil Tascioglu Cith Hospital
Istanbul, Sisli
Alper Otunctemur, Assoc.Prof., 5325423686 ext. +90, alperotunctemur@yahoo.com
About this study
Official title: 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.
- Being tested
- IIEF-5
- Medical subject headings
- Erectile Dysfunction, Nocturia, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIEF-5Diagnostic test
IIEF-15 form will be filled out by all participants
| Study group | Role | What they receive |
|---|---|---|
| Nightshift workers | Not described Receives: Diagnostic Test: IIEF-5 | |
| Non-nightshift workers | Not described Receives: Diagnostic Test: IIEF-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile dysfunction
Decreased scores of IIEF-5
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start20 Nov 2020
- Primary completion20 May 2021 (estimated)
- Study completion20 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, gokhan calik, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707807
- Sponsor's protocol ID
- MedipolUrology
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nightshift Work and Sleep Disturbances on Erectile Function, Serum Testosterone Levels, Nocturia
- ClinicalTrials.gov ID
- NCT04707807
- Acronym / sponsor ID
- MedipolUrology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 20 Nov 2021 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nightshift workers | – | Diagnostic Test: IIEF-5 |
| Non-nightshift workers | – | Diagnostic Test: IIEF-5 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Suffering from erectile dysfunction
- Mainly psychogenic ED
- Employed
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IIEF-5IIEF-15 form will be filled out by all participants | Diagnostic test | Nightshift workers, Non-nightshift workers |
Primary outcome
Erectile dysfunction
Time frame: 3-6 months
Decreased scores of IIEF-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, Nocturia, Short Term Insomnia, Obstructive Sleep Apnea, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gokhan Calik, Asst.Prof. (+905362666604, gcalik@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile dysfunction (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.