Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Sleep Clinical Trial

— CLASS-D  

Official title:

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04206059
• Other study ID #: 201907086
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Sedation Complication
• Sleep

Intervention

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.
• 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
• 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)
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in EEG slow wave amplitude from sham to in-phase stimulation	EEG slow waves amplitude relative to the timing of the stimulation	up to 3 months after consent
Primary	Difference in EEG slow wave duration from sham to in-phase stimulation	EEG slow waves duration relative to the timing of the stimulation	up to 3 months after consent
Primary	Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation	EEG slow waves amplitude relative to the timing of the stimulation	up to 3 months after consent
Primary	Difference in EEG slow wave duration from anti-phase to in-phase stimulation	EEG slow waves duration relative to the timing of the stimulation	up to 3 months after consent
Secondary	Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation	Threshold for responsiveness to thermal stimulation	up to 3 months after consent
Secondary	Difference of reactivity to thermal stimulation from sham to in-phase stimulation	Threshold for responsiveness to thermal stimulation	up to 3 months after consent
Secondary	Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session.	Slow wave activity calculated during N3 sleep	up to 3 months after consent
Secondary	Localization of slow waves	Brain regions with localization of EEG slow waves during dexmedetomidine sedation	up to 3 months after consent