Closed-Loop Acoustic Stimulation During Sedation with Dexmedetomidine (CLASS-D): Protocol for a Within-Subject, Crossover, Controlled, Interventional Trial with Healthy Volunteers

Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults

“…2 a). 31

Fig 2 Study overview with corresponding EEG hypnograms and spectrograms from a single participant. (a) Participants utilised a wireless wearable EEG device to record their pre- and post-sedation sleep at home, and high-density EEG recordings were obtained during daytime dexmedetomidine sedation with CLAS.

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“…Over the following 100–200 min, CLAS of EEG slow-delta waves and thermal arousal thresholds were evaluated according to the protocol using a crossover design, where each participant was exposed to both in-phase and anti-phase CLAS. 31 Dexmedetomidine plasma concentrations were measured from blood sampled at steady-state, before and after CLAS. 31 Dexmedetomidine was discontinued while participants were monitored for return of responsiveness.…”

“… 31 Dexmedetomidine plasma concentrations were measured from blood sampled at steady-state, before and after CLAS. 31 Dexmedetomidine was discontinued while participants were monitored for return of responsiveness. Once participants were considered responsive (performing the behavioural task correctly for five consecutive breaths), EEG acquisition was stopped.…”

“…Sample size calculations were based on the main study outcomes of enhancement of EEG slow waves between CLAS conditions and not on the secondary outcomes of this manuscript. 31 …”