Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Not Applicable

Active, not recruiting

• Conditions: Sleep; Sedation Complication
• Interventions: Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: Acoustic stimulation (65db) up-slope of EEG with QST; Other: Acoustic stimulation (65db) down-slope of EEG with QST; Other: 0 db with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task

• Registration Number: NCT04206059
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-20
• Study Start: 2021-01-20
• Primary Completion: 2022-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLASS-D Cohort	Quantitative Sensory Testing (QST)	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	Acoustic stimulation (65db) up-slope of EEG with QST	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	MRI	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	Breathe-Squeeze Task	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	Acoustic stimulation (65db) down-slope of EEG with QST	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	0 db with QST	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	Home sleep study	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
CLASS-D Cohort	Dexmedetomidine	Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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
Localization of slow waves	up to 3 months after consent	Brain regions with localization of EEG slow waves during dexmedetomidine sedation
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

Trial Locations

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States