NCT04206059

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep
• Sedation Complication

Interventions

Type	Name	Description
RADIATION	MRI	A non-contrast brain MRI will be acquired for localizing EEG slow waves
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.
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.
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
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)
OTHER	0 db with QST	sham stimulation (0 dB volume)
DRUG	Dexmedetomidine	All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
OTHER	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.

Timeline

• Start date: 2021-01-20
• Primary completion: 2022-06-01
• Completion: 2023-07-01
• First posted: 2019-12-20
• Last updated: 2022-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study