drugset / Trial / NCT04206059
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Non-randomizedCrossoverDouble-blindDiagnostic
Summary
Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves. Anti-phase stimulation will serve as an active control while sham stimulation will serve as a passive control.
Timeline
- Start
- 2021-01-20
- Primary completion
- 2022-06-01
- Completion
- 2023-07-01
Publications
- Background Prerau MJ, Brown RE, Bianchi MT, Ellenbogen JM, Purdon PL. Sleep Neurophysiological Dynamics Through the Lens of Multitaper Spectral Analysis. Physiology (Bethesda). 2017 Jan;32(1):60-92. doi: 10.1152/physiol.00062.2015.
- Background Leger D, Debellemaniere E, Rabat A, Bayon V, Benchenane K, Chennaoui M. Slow-wave sleep: From the cell to the clinic. Sleep Med Rev. 2018 Oct;41:113-132. doi: 10.1016/j.smrv.2018.01.008. Epub 2018 Feb 5.
- Background Neske GT. The Slow Oscillation in Cortical and Thalamic Networks: Mechanisms and Functions. Front Neural Circuits. 2016 Jan 14;9:88. doi: 10.3389/fncir.2015.00088. eCollection 2015.
- Smith SK, Kafashan M, Rios RL, Brown EN, Landsness EC, Guay CS, Palanca BJA. Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults. BJA Open. 2024 Mar 28;10:100276. doi: 10.1016/j.bjao.2024.100276. eCollection 2024 Jun.
- Guay CS, Hight D, Gupta G, Kafashan M, Luong AH, Avidan MS, Brown EN, Palanca BJA. Breathe-squeeze: pharmacodynamics of a stimulus-free behavioural paradigm to track conscious states during sedation☆. Br J Anaesth. 2023 May;130(5):557-566. doi: 10.1016/j.bja.2023.01.021. Epub 2023 Mar 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 2 ng/ml | — |
| Subject | Dexmedetomidine | Other / unclassified | 3 ng/ml | — |
| Subject | Dexmedetomidine | Other / unclassified | 4 ng/ml | — |
Indications
No indication recorded.