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Sleep Clinical Trials

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry: ADHERE UAS Registry

Aims: The purpose of this research study is gather information from the Inspire® Upper Airway Stimulation (UAS) System device on its use and performance. The information collected will continue to educate physicians who treat obstructive sleep apnea (OSA).
Principal Investigator: Mari Viola-Saltzman, MD
NorthShore Project Number: EH19-321
Contact: Call 847.503.4333 with questions regarding the study
Open to Enrollment: Yes

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients with Idiopathic Hypersomnia

 Aim: The purpose of the study is to evaluate the safety and efficacy of pitolisant (HBS-101) compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH).  The study consists of a screening period (up to 28 days), an 8-week open-label phase, and a 4-week double-blind randomized withdrawal phase. After completion of the screening phase, eligible patients will be enrolled in the open-label phase, which includes 6-week optimization (titration) phase and a 2-week stable dose period. At the end of the stable dose period, safety, efficacy, pharmacokinetic (PK), and genotype assessments will be collected, and patients will be categorized as “responders” or “non-responders.”  A responder is defined as an individual who has achieved a decrease of ≥3 points in their Epworth Sleepiness Scale (ESS) score from Baseline (Day -1) to the end of the Stable Dose Period. Responders will be randomized in a 1:1 ratio to receive blinded study drug (pitolisant or matching placebo) in the double-blind randomized withdrawal phase of the study. Non-responders will not be randomized to treatment in the double-blind randomized withdrawal phase, but will complete two safety follow-up telephone contacts at 15 and 30 days after their final dose of open-label pitolisant. These follow-ups will include assessment for adverse events and concomitant medication use.
Principal Investigator: Thomas Freedom, MD   
NorthShore Project Number: EH22-171
Contact: Call 847.570.1864 with questions regarding the study
Open to Enrollment: Yes