Feeling excessively tired during your shift? This study explores an investigational medication for shift work disorder (SWD), aiming to address excessive sleepiness. With limited approved treatments available, researchers want to know if the investigational medication can improve wakefulness during night shifts for people with SWD and if it is safe for use in this population.

By participating, you can help advance understanding of this condition and gain valuable insights into your own symptoms. Join this study to contribute to safer workplaces and improved treatments for shift workers

• Men and women aged 18-65 who work at least 5 night shifts per month, with at least 2 of the night shifts occurring on consecutive nights
• Must work night shifts that include at least 6 hours between 10 PM (22:00h) and 8 AM (08:00h), and be no longer than 12 hours in duration
• Must be planning on maintaining their work schedule throughout the duration of the study
• Must have complaints of excessive sleepiness during night shifts, and does not have any medical or psychiatric disorders that could account for the excessive sleepiness during night shifts
• Must not have a diagnosis or probable diagnosis of a current sleep disorder other than shift work disorder (SWD) (e.g., moderate to severe obstructive sleep apnea, narcolepsy, idiopathic hypersomnia, periodic limb movement disorder, restless legs syndrome, etc.)

• Must not have attempted suicide within the last 2 years or currently have suicidal ideation
• Must not have any of the following:

• Lifetime history of or presentation consistent with schizophrenia, schizoaffective disorder, or any other psychotic disorder
• Bipolar disorder (including bipolar I and bipolar II)
• Borderline, antisocial, or narcissistic personality disorder
• Post-traumatic stress disorder
• Obsessive-compulsive disorder
• Psychiatric disorder leading to hospitalization

• Must be able to attend up to 6 clinic visits at the research site and 8 remote visits over approximately 4 months. Three of these visits will last up to approximately 25 hours. 

• You may receive the investigational medication.  
• You may receive study-related care and study evaluations at no cost.  
• You may also receive $160 for each study visit, with total compensation of up to $2,672 for completing the study. An additional $250 may be provided for completing sleep diaries. 
• You may have the opportunity to help advance potential new treatments for people with shift work disorder. 

The study team will explain the research in its entirety but some details are:

• Participants will be asked to provide informed consent, agreeing to comply with all study requirements, including dosing, restrictions, and attending required assessments.
• Participants will be asked to undergo various assessments such as vital sign measurements, physical exams, ECGs, blood and urine tests (including pregnancy and drug and alcohol screenings), and sleep studies.
• Participants will be asked to complete questionnaires, maintain an electronic shift work diary, and take the assigned study medication or placebo*.
• *A placebo is a pill that looks like the study drug but does not contain any active ingredients.

Dr. Christopher Drake is a board-certified sleep specialist and internationally recognized expert in sleep and circadian rhythm disorders. He is a professor of medicine at the Michigan State College of Human Medicine and serves as the Director of Sleep Research for Henry Ford Health where he oversees NIH and Industry clinical trials in insomnia, narcolepsy, idiopathic hypersomnia, sleep apnea, and depression. He is the Insomnia Section Editor for Principles and Practice of Sleep Medicine and serves as Associate Editor for SLEEP, Sleep Advances, and Behavioral Sleep Medicine. Recently, he co-authored The Wisdom of Dreams: Science, Synchronicity, and the Language of the Soul, Routledge. He served as Chairman of the National Sleep Foundation from 2013-2014. and received the Distinguished Service Award from the Sleep Research Society in 2015. In 2016, Dr. Drake Received the Pioneer Award from the Robert Wood Johnson Foundation. He has been funded by the National Institutes of Health since 2004 and has authored over 200 peer-reviewed publications in the field.

Dr. Christopher Drake

Research Site:

Henry Ford Medical Center - Columbus 

Location:

39450 W 12 Mile Rd Novi, MI 48377

Lead Researcher:

Dr. Christopher Drake

Ethics Committee:

This study has been reviewed and approved by the Advarra Institutional Review Board and Henry Ford Health IRB Administration Office. You may contact Henry Ford Health IRB by phone at (313) 874-4464 or by email at irbquestions@hfhs.org.

Henry Ford Health is one of the nation’s leading academic medical centers, recognized for clinical excellence in cancer care, cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, and multi-organ transplants. Consistently ranked among the top five NIH-funded institutions in Michigan, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents, and fellows every year across 50+ accredited programs.

Qualified health professionals will monitor your health as it relates to the study.

This trial has been reviewed and approved by an independent ethics committee. 

All research staff that are running this trial have been trained in GCP, which assures that the rights, safety, and well-being of research subjects are protected and respected.

We follow all established national privacy standards used in all doctors' offices, hospitals and other businesses where personal medical information is stored.

All data you provide us is encrypted and stored safely and securely in accordance with security and privacy rules.

Informed Consent Before Participation

Withdraw At Any Time

Strictly Confidential

Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.

You will receive a detailed outline of all details of the study, including treatment, risks and procedures, and given the chance to ask questions to study staff, before you decide whether to participate.

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