HYPNAGOGIC/HYPNOPOMPIC HALLUCINATION TYPES AMONG PARTICIPANTS WITH NARCOLEPSY TYPE 1 FROM THE PHASE 3 REST-ON TRIAL

Document Type

Conference Proceeding

Publication Date

5-19-2025

Publication Title

Sleep

Abstract

Introduction: Limited information is available to quantify hypnagogic/hypnopompic hallucination (HH) events people with nar colepsy (PWN) may experience. This post hoc analysis from the phase 3 REST-ON trial evaluated individual HH types. Methods: REST-ON (NCT02720744) participants (age ≥16 years) with narcolepsy were randomized 1:1 to once-nightly sodium oxybate (ON-SXB) (week 1, 4.5 g; weeks 2-3, 6 g; weeks 4-8, 7.5 g; weeks 9-13, 9 g) or placebo. HH events were assessed in participants with narcolepsy type 1. Modified intent-to-treat (mITT) population (≥1 efficacy measurement after 6-g dose) data were analyzed. Nocturnal HH types were evaluated via 6 yes/no questions and recorded in daily diaries. Daytime HHs were not assessed. Results: In the mITT population with HH at baseline (n=112 [ON-SXB, n=55; placebo n=57]), baseline mean [SD] number of HH events/day was 0.60 [0.35] and 0.66 [0.35] in the ON-SXB and placebo groups, respectively. Respective mean change from baseline (95% CI) in HH events/day to weeks 3, 8, and 13 was −0.16 (−0.21, −0.11), −0.28 (−0.37, −0.19), and −0.29 (−0.40, −0.18) with ON-SXB (all P< 0.001) and −0.14 (−0.20, −0.08), −0.18 (−0.26, −0.10), and −0.24 (−0.33, −0.14) with placebo (all P< 0.001). Participants chose from the following HH types: 1) feeling that shadows or objects are moving/distorting (total number of events with ON-SXB and placebo: 1693 and 2133), 2) feeling another presence in the room (1362 and 1839), 3) feeling that you are about to be attacked (655 and 1232), 4) feeling that you are flying through the air (543 and 1351), 5) feeling that you will soon fall into a hole (448 and 914), and 6) feeling caught in a fire (123 and 152). Of 12,455 HH events, 7762 (62%) were hypnagogic, and 4683 (38%) were hypnopompic. Conclusion: There were low baseline HH rates in REST-ON, and a strong placebo effect was observed. However, these data provide insight into the HH types participants experienced. Relevant to clinician-patient discussions, approximately half the number of events where participants felt like they were about to be attacked, flying through the air, and falling in a hole were reported with ON-SXB vs placebo.

Volume

48

First Page

A361

Last Page

A362

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