Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Henry Ford Health System – Sleep Research Center
Location: 39450 W. 12 Mile Rd. Novi, MI 48337 
Lead Doctor: Christopher L. Drake, Ph.D.
IRB Committee: This study has been reviewed and approved by the Henry Ford Health System Institutional Review Board

Background

According to the National Institute of Neurological Disorders, about 135,000 to 200,000 people in the United States have narcolepsy. Narcolepsy is a long-term sleep disorder that causes daytime drowsiness. People with narcolepsy may or may not experience cataplexy. About 70% of people with narcolepsy experience cataplexy. Cataplexy is identified by having recurrent episodes of a sudden muscle weakness, although fully conscious.

Researchers are developing ways to help those experiencing narcolepsy. This study seeks to determine the effectiveness of a new potential treatment. 

This study is looking for adults aged 18 to 50 years old who have been diagnosed with narcolepsy. Participants must be willing to comply with all the necessary study requirements. Compensation will be provided to eligible participants.

Why Participate? 

• You may experience potential improvements to your narcolepsy symptoms.
• You may contribute valuable information that may benefit others in the future. 
• You will be helping to advance medical research.
• Your involvement in this study is appreciated. The following payments will be made to compensate you for your time and to reimburse you for transportation or parking payments related to visiting the study center: 2 payments of $74 for the Screening and Safety Follow-up visits as well as 3 payments of $250 for Visit 1, Visit 2 and Visit 3.

Your Rights

• 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.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Adults aged 18 to 50 years old who are diagnosed with narcolepsy.
• Able to attend 5 study visits at the research site over approximately 7 weeks.
  • Participants must be willing to take the potential treatment every morning for 14 days.
  • Participants must be willing to come to the research center for an overnight visit at the research site.
  • Participants must be willing to do a follow-up visit 7 days after their last dose of the potential treatment. 
  • Participants must be willing to complete a sleep diary throughout the study.

About The Research Center:

 
Henry Ford Health System – Sleep Research Center
When you come to the Henry Ford Health System for diagnosis and treatment of sleep-related conditions, you will find some of the nation’s top sleep disorder specialists. Our caring team uses the most up-to-date, scientific methods and comprehensive strategies to effectively treat every patient. We also have clinic and sleep lab locations across southeast and south central Michigan.

Please note:

Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:

• The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
• The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
• Hand sanitisers are available at the research site.
• The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
• Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
• Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
• Parking is available at the research site.
• The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. All travel expenses will be reimbursed.
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants.