Functional Impact of Narcolepsy Instrument in Narcolepsy Type 2
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 23-000533
Sponsor Protocol Number: TK1051C
About this study
The overall objective of this research is to explore whether the Functional Impacts of Narcolepsy Instrument - Central Disorders of Hypersomnolence (FINI-CDH) is a fit-for-purpose assessment of functional outcomes in NT2. This research will ensure applicability of the FINI-CDH in this population.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- The participant must be aged 18 to 70 years, inclusive, at the time of informed consent.
- The participant must have a diagnosis of NT2 by PSG/MSLT performed within the past 10 years demonstrating the minimal acceptable criteria for the proper performance of PSG/MSLT as outlined by the ICSD-3 criteria.
- The participant’s ESS score must be ≥10 at screening.
- The participant must understand the study and agree to participate by providing written informed consent.
Exclusion Criteria:
- The participant has a current or prior history of substance abuse disorder in the last year prior to the screening visit per the Diagnostic and Statistical Manual of Mental Disorders-V criteria.
- The participant has a medical disorder, other than NT2, associated with excessive daytime sleepiness. This includes clinically significant obstructive sleep apnea or restless legs syndrome, fibromyalgia.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/17/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Lois Krahn, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available