Lois E. Krahn, M.D.

The purpose of this study is to evaluate the safety, tolerability and effectiveness of BTD-001 in subjects with idiopathic hypersomnia (IH) as reflected by changes in mental fogginess, sleep, functional, and quality-of-life measures.

The purpose of this study istoevaluate the effectiveness and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.

The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

The purpose of this study is to evaluate the safety, tolerability and effectiveness of BTD-001 in subjects with idiopathic hypersomnia (IH) as reflected by changes in mental fogginess, sleep, functional, and quality-of-life measures.

The purpose of this study is to assess the safety and effectiveness of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

The purpose of this study is to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.

The purpose of this study is to test the usefullness and initial effectiveness of an mHealth smartphone app to increase use of positive airway pressure (PAP) therapy in obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine.

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.

The purpose of this study is to assess with objective data if the presence of a dog in the bedroom disturbs their human's sleep.