Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine (CLASS-D)

The Washington University

Status

Active, not recruiting

Conditions

Sedation Complication

Sleep

Treatments

Diagnostic Test: Home sleep study

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

Drug: Dexmedetomidine

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

Other: Breathe-Squeeze Task

Other: 0 db with QST

Diagnostic Test: Quantitative Sensory Testing (QST)

Radiation: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT04206059

201907086

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

CLASS-D Cohort

Experimental group

Description:

Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.

Treatment: