Sleep, Sedation Complication
Conditions
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.
Interventions
RADIATIONMRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
DIAGNOSTIC_TESTQuantitative 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_TESTHome 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.
OTHERAcoustic stimulation (65db) up-slope of EEG with QST
Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
OTHERAcoustic stimulation (65db) down-slope of EEG with QST
65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
OTHER0 db with QST
sham stimulation (0 dB volume)
DRUGDexmedetomidine
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
OTHERBreathe-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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 anti-phase to in-phase stimulation | up to 3 months after consent | EEG slow waves amplitude relative to the timing of the stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Localization of slow waves | up to 3 months after consent | Brain regions with localization of EEG slow waves during dexmedetomidine sedation |
Countries
United States
Outcome results
None listed