Clinical trial NCT04206059: Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Official title: Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Sedation Complication
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).

Exclusion Criteria:

* Diagnosed sleep disorders
* Habitually short sleepers
* Diagnosed psychiatric disorders
* Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
* Neck circumference \> 40 cm
* Body Mass Index \> 30
* Acknowledged recreational drug or nicotine use
* Resting heart rate during slow wave sleep \< 40 beats per minute
* Pregnancy or nursing
* Persistently inconsistent or elevated QST heat pain tolerance thresholds (\>50 ºC).

Primary outcomes:
measure: Difference in EEG slow wave amplitude from sham to in-phase stimulation
timeFrame: up to 3 months after consent
measure: Difference in EEG slow wave duration from sham to in-phase stimulation
timeFrame: up to 3 months after consent
measure: Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation
timeFrame: up to 3 months after consent
measure: Difference in EEG slow wave duration from anti-phase to in-phase stimulation
timeFrame: up to 3 months after consent
Secondary outcomes:
measure: Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation
timeFrame: up to 3 months after consent
measure: Difference of reactivity to thermal stimulation from sham to in-phase stimulation
timeFrame: up to 3 months after consent
measure: Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session.
timeFrame: up to 3 months after consent
measure: Localization of slow waves
timeFrame: up to 3 months after consent
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ben J Palanca, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.