Participant disposition and baseline characteristics
hypoxemia, comorbid sleep disorders
RECRUITMENT
A total of 28 participants meeting criteria for IH (as described earlier) were enrolled and randomized. The stopping criteria based on changes in sleep latency in the MWT were met in the planned interim analysis and further recruitment into the study was terminated early. One participant was randomized but not treated owing to difficulties inserting the infusion line. Of 27 participants receiving treatment, two discontinued the study after receiving placebo and never received danavorexton; one was randomized in error, despite not meeting PSG criteria, and another was accidentally registered as an early termination by the study site (Baseline characteristicsBMI, body mass index; ESS, Epworth Sleepiness Scale; KSS, Karolinska Sleepiness Scale; MWT, maintenance of wakefulness test; SD, standard deviation.
Participant disposition. *nPSG inclusion criteria, evaluated at study day −2, demonstrated that subjects had no other comorbid sleep disorders or clinically significant nocturnal hypoxemia (O