Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Difference in EEG slow wave duration from sham to in-phase stimulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).
排除标准
- •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).
研究组 & 干预措施
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: MRI (Radiation)
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: Quantitative Sensory Testing (QST) (Diagnostic Test)
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: Home sleep study (Diagnostic Test)
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: Acoustic stimulation (65 decibels or db) up-slope of EEG with QST (Other)
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: Dexmedetomidine (Drug)
CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
干预措施: Breathe-Squeeze Task (Other)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: MRI (Radiation)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: Quantitative Sensory Testing (QST) (Diagnostic Test)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: Home sleep study (Diagnostic Test)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: Acoustic stimulation (65db) down-slope of EEG with QST (Other)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: Dexmedetomidine (Drug)
CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
干预措施: Breathe-Squeeze Task (Other)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: MRI (Radiation)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: Quantitative Sensory Testing (QST) (Diagnostic Test)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: Home sleep study (Diagnostic Test)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: 0 db with QST (Other)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: Dexmedetomidine (Drug)
CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
干预措施: Breathe-Squeeze Task (Other)
结局指标
主要结局
Difference in EEG slow wave duration from sham to in-phase stimulation
时间窗: 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
时间窗: up to 3 months after consent
EEG slow waves amplitude relative to the timing of the stimulation
Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation
时间窗: up to 3 months after consent
EEG slow waves amplitude relative to the timing of the stimulation
Difference in EEG slow wave duration from anti-phase to in-phase stimulation
时间窗: up to 3 months after consent
EEG slow waves duration relative to the timing of the stimulation
Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation
时间窗: Sham stimulation and in-phase stimulation blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation
时间窗: Anti-phase and in-phase blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation
时间窗: anti-phase and in-phase blocks during the intervention
Difference in EEG slow wave density from anti-phase to in-phase stimulation by looking at EEG slow waves duration relative to the timing of the stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Difference in EEG Slow Wave Density From Sham to In-phase Stimulation
时间窗: Sham stimulation and in-phase stimulation blocks during the intervention
Difference in EEG slow wave density from sham to in-phase stimulation by looking at EEG slow waves relative to the timing of the stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
次要结局
- Difference of reactivity to thermal stimulation from sham to in-phase stimulation(up to 3 months after consent)
- Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation(up to 3 months after consent)
- Localization of slow waves(up to 3 months after consent)
- 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)
- Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation(Anti-phase and in-phase blocks of the intervention)
- Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation(Sham and in-phase blocks during intervention)
- Slow Wave Activity Calculated During N3 Sleep(on the nights before and the night of the intervention)
研究者
Ben J.A. Palanca
Assistant Professor
Washington University School of Medicine