1106 Patient-Centric Design: Incorporating Patient Input into a Clinical Study of Idiopathic Hypersomnia and Narcolepsy

Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment; NCT05875974) is a phase 4, prospective, multicenter, single-arm, open-label interventional study that comprehensively evaluates low-sodium oxybate effects on sleep architecture and daytime/nighttime symptoms in participants with idiopathic hypersomnia or narcolepsy. Multiple assessments, including overnight polysomnography (PSG), are needed to generate robust, relevant data, but these assessments may impose a burden on study participants. A patient advisory board was convened to understand patient perspectives and assess opportunities to incorporate patient feedback into the study protocol. Methods Advisors completed a premeeting survey, then attended a 3-hour advisory board meeting with the study sponsor. Five main topics were discussed: feasibility of oxybate washout for participants entering the study on treatment, burden of assessments, relevance of specific symptom evaluation to participants, value of reporting individualized data back to participants, and burden of overnight visits. Results The advisory board included 2 people with idiopathic hypersomnia and 4 people with narcolepsy. All 6 advisors had experience with patient advocacy, and at least 1 had been a clinical trial participant; these experiences may help give voice to a broader patient community. Premeeting survey responses were reviewed and discussed during the meeting. Based on advisor input, the final study protocol incorporated several points, including support for participants undergoing oxybate washout (eg, transportation, childcare, and meal service, as needed), additional breaks between assessments, moving assessments from evening to morning to reduce participant burden, measuring fatigue separately from sleepiness, and suggestions to make participants more comfortable for overnight visits. Advisors noted the high value of reporting individualized data back to study participants—particularly PSG data, with specific interest in number of awakenings, duration of rapid eye movement sleep, and duration of slow-wave sleep. In addition to these changes, study materials were developed to help participants prepare for overnight visits, and a checklist of items to bring to these visits was created. Conclusion The final DUET study design incorporated patient-centric elements recommended by a patient advisory board. Implementation of these elements is anticipated to reduce participant burden, improve participant experience, enhance recruitment and retention, and facilitate collection of meaningful and comprehensive data. Support (if any) Jazz Pharmaceuticals