Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Sedation Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI

Intervention Type RADIATION

A non-contrast brain MRI will be acquired for localizing EEG slow waves

Quantitative Sensory Testing (QST)

Intervention Type DIAGNOSTIC_TEST

Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.

Home sleep study

Intervention Type DIAGNOSTIC_TEST

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.

Acoustic stimulation (65db) up-slope of EEG with QST

Intervention Type OTHER

Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves

Acoustic stimulation (65db) down-slope of EEG with QST

Intervention Type OTHER

65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)

0 db with QST

Intervention Type OTHER

sham stimulation (0 dB volume)

Dexmedetomidine

Intervention Type DRUG

All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml

Breathe-Squeeze Task

Intervention Type OTHER

All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.

Interventions

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MRI

A non-contrast brain MRI will be acquired for localizing EEG slow waves

Intervention Type RADIATION

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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Acoustic stimulation (65db) up-slope of EEG with QST

Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves

Intervention Type 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)

Intervention Type OTHER

0 db with QST

sham stimulation (0 dB volume)

Intervention Type OTHER

Dexmedetomidine

All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml

Intervention Type DRUG

Breathe-Squeeze Task

All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.

Intervention Type OTHER

Other Intervention Names

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Structural magnetic resonance imaging Quantitative Sensory Testing Unattended polysomnography In-phase CLAS with sensory testing Anti-phase CLAS with sensory testing Sham CLAS with sensory testing Dexmedetomidine hydrochloride Internally directed behavioral task

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes