Trial design
RECRUITMENT
This randomized, double-blind, placebo-controlled, parallel-group trial was conducted at the Stanford Sleep Medicine Center. Recruitment started in September 2019 and ended in October 2021 after enrollment of 24 participants and the trial ended in January 2022. Participants were randomly assigned to receive SXB or placebo of similar appearance and taste nightly with 1:1 ratio. The trial consisted of a 4-week baseline, followed by a titration of at least 4 weeks, a 4-week stable dosing period, and a 2-week withdrawal period. All participants provided written consent. The study was approved by the Stanford Institutional Review Board and the design was in accordance with the Declaration of Helsinki. The trial was registered on ClinicalTrials.gov (Identifier: NCT04006925).