N/A
N=16
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Sleep · Sedation Complication
Bottom Line
View on ClinicalTrials.gov: NCT04206059 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation — 1.592; 1.694 Log(μV squared)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI (Radiation); Quantitative Sensory Testing (QST) (Diagnostic_test); Home sleep study (Diagnostic_test); Acoustic stimulation (65 decibels or db) up-slope of EEG with QST (Other); Acoustic stimulation (65db) down-slope of EEG with QST (Other); 0 db with QST (Other); Dexmedetomidine (Drug); Breathe-Squeeze Task (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation |
1.592; 1.694 | — |
| PRIMARY Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation |
1.511; 1.694 | — |
| PRIMARY Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation |
6.9; 6 | — |
| PRIMARY Difference in EEG Slow Wave Density From Sham to In-phase Stimulation |
6; 4.3 | — |
| SECONDARY Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation |
48.2; 50.5 | — |
| SECONDARY Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation |
48.5; 50.5 | — |
| SECONDARY Slow Wave Activity Calculated During N3 Sleep |
8830 | 0.57 |
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.
Eligibility Criteria
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 50 ºC).
Data sourced from ClinicalTrials.gov (NCT04206059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.