CLASS-D: Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Both nonpharmacologic and pharmacologic interventions augment expression of EEG slow waves that mimic those of natural sleep. Closed loop auditory stimulation (CLAS) is a noninvasive inexpensive approach to augment the spectral power and duration of these slow waves. Whether in-phase CLAS may address this need is unknown, since acoustic potentiation of pharmacologically-induced slow waves has not been investigated. This prospective within-subject study of dexmedetomidine sedation paired with CLAS will assess the feasibility of augmenting EEG slow waves during sedation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CLASS-D Cohort Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation. |
Radiation: MRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
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Diagnostic Test: Quantitative Sensory Testing (QST)
Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
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Diagnostic Test: Home sleep study
Unattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.
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Other: Acoustic stimulation (65db) up-slope of EEG with QST
Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
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Other: Acoustic stimulation (65db) down-slope of EEG with QST
65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
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Other: 0 db with QST
sham stimulation (0 dB volume)
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Drug: Dexmedetomidine
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
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Outcome Measures
Primary Outcome Measures
- Difference in EEG slow wave amplitude from sham to in-phase stimulation [up to 3 months after consent]
EEG slow waves amplitude relative to the timing of the stimulation
- Difference in EEG slow wave duration from sham to in-phase stimulation [up to 3 months after consent]
EEG slow waves duration relative to the timing of the stimulation
- Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation [up to 3 months after consent]
EEG slow waves amplitude relative to the timing of the stimulation
- Difference in EEG slow wave duration from anti-phase to in-phase stimulation [up to 3 months after consent]
EEG slow waves duration relative to the timing of the stimulation
Secondary Outcome Measures
- Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation [up to 3 months after consent]
Threshold for responsiveness to thermal stimulation
- Difference of reactivity to thermal stimulation from sham to in-phase stimulation [up to 3 months after consent]
Threshold for responsiveness to thermal stimulation
- Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session. [up to 3 months after consent]
Slow wave activity calculated during N3 sleep
- Localization of slow waves [up to 3 months after consent]
Brain regions with localization of EEG slow waves during dexmedetomidine sedation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-40 years
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Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).
Exclusion Criteria:
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Diagnosed sleep disorders
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Habitually short sleepers
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Diagnosed psychiatric disorders
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Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
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Neck circumference > 40 cm
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Body Mass Index > 30
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Acknowledged recreational drug or nicotine use
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Resting heart rate during slow wave sleep < 40 beats per minute
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Pregnancy or nursing
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Persistently inconsistent or elevated QST heat pain tolerance thresholds (>50 ºC).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine/Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Ben J Palanca, MD PhD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Léger 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. Review.
- 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. Review.
- 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. Review.
- 201907086