A Study to Analyze Concept Elicitation and Content Validation for Narcolepsy Type 2 and Idiopathic Hypersomnia

Overview

About this study

This study will involve in-depth, qualitative interviews with adults who have a diagnosis of NT2 (N = 15), who meet the agreed inclusion/exclusion criteria. All interviews will be undertaken in the United States (US). Each participant will take part in two interviews; each interview will last approximately 75 minutes, and interviews will be completed within seven days of each other. The interviews will be semi-structured, using a discussion guide, and all will be conducted by a trained interviewer. The interviews will be conducted via telephone, or face-to-face using a web-assisted platform.
Interview 1 will consist of a concept elicitation (CE) discussion, meaningful change exercise and discussion using two global items, and a cognitive debrief (CD) of the symptom domain of the Pilot-NT2-Items.
 The CE discussion will involve an open-ended, participant-led discussion designed to explore the symptoms and impacts experienced by adults who have NT2; this section of the interview will last approximately 40 minutes.
 In the second section of interview 1, participant responses to the patient global impression of improvement (PGI-I) and severity (PGI-S) items will be explored, in order to inform an anchor definition to derive a meaningful change threshold (MCT) on the measure of interest. This section will last approximately 15 minutes.
 The final section of the interview will involve a CD of the symptom domain of the Pilot-NT2-Items to confirm the relevance and understanding of this domain, and its response options. This section will last approximately 10 minutes.
 The participant will not look at the global items or the Pilot-NT2-Items until after the CE section of the interview is complete.
Interview 2 will consist of a CD of remaining domains of the Pilot-Nt2-Items: fatigue, cognition, work, social and other function. The interview will follow the same procedures as the CD conducted in interview 1 and will take approximately 75 minutes.
No therapeutic intervention or treatment will be administered as part of this study.

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 - NT2 Participants:

The participant must be aged 18 to 65 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 - NT2 Participants:

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.

Inclusion Criteria - IH Participants:

The participant must be aged 18 to 65 years, inclusive, at the time of informed consent.
The participant must have a diagnosis of IH by PSG and 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 - IH Participants:

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 IH, associated with excessive daytime sleepiness. This includes clinically significant obstructive sleep apnea or restless legs syndrome, fibromyalgia.

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
Rochester, Minn. Mayo Clinic principal investigator Lois Krahn, M.D.	Closed for enrollment
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Lois Krahn, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Closed for enrollment

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