The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in frontolimbic emotional reactivity circuit activity
研究概览
简要总结
In this study, the investigators will recruit young adults (ages 18-25 years) with elevated anxiety/depression symptoms and sleep disturbance. Participants will complete two overnights in a sleep lab. During one of the overnights, slow-wave activity will be enhanced by delivering sub-arousal auditory tones during slow-wave sleep using a headband device (Philips SmartSleep or Dreem 2). During the other overnight, tones will not be administered. Cognitive and emotional processes will be evaluated using behavioral task performance, self-report, and functional magnetic resonance imaging (fMRI). After the second overnight, participants will take the headband device home and wear it every night for approximately 2 weeks. For half of the participants, the headband will play tones every night and, for the other half, the headband will not play tones. Participants will then return for a final testing visit in which cognitive and emotional processes and anxiety/depression symptoms will be assessed using behavioral task performance and self-report.
详细描述
When interested participants are identified through recruitment methods, they will be directed to complete an online screening survey. The aim of this screening is to ensure that participants meet minimal study inclusion/exclusion criteria and to avoid an unnecessary in-person visit to the lab.
Based on the online screening, eligible participants will be contacted by study personnel for scheduling for the in-lab baseline visit. During the baseline visit, informed consent will be obtained. The investigators will also perform additional screening, a hearing test, and an audio recording of the participant singing in preparation for the karaoke task (described below). Finally, participants will be given a wrist actigraphy device and will be sent a daily electronic sleep diary with which to track their sleep at home for approximately 1-week before each overnight session. Participants will be told to maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes) for one week before each overnight. Sleep diary and actigraphy will be used to verify compliance. Participants will also be asked to refrain from alcohol and recreational drug use for 48hrs before each in-lab overnight session and will be asked to refrain from consuming caffeine after Noon on the day of their overnight visits. Participants will also be asked to wear the headband device for one night at home prior to each overnight visit to get acclimated to the feel.
Approximately 1-2 weeks later, participants will return for their first overnight visit. They will be screened for drug/alcohol use through a subjective questionnaire. Prior to sleep, participants will complete a set of tasks and questionnaires assessing mood, sleepiness, cognition, and emotional processing. The primary tasks will include a modified AX-CPT cognitive control task and a karaoke task.
After completing these tasks, participants will be randomized in counterbalanced order to receive acoustic stimulation during sleep (STIM) or a control night with no acoustic stimulation (SHAM). Participants will remain blind to condition. During STIM, participants will wear a headband device (Philips SmartSleep or Dreem 2), which presents sub-arousal tones during slow-wave sleep to boost underlying slow-wave activity. During SHAM, participants will wear the same device, but no tones will be administered. During both nights, participants will also be set up with standard polysomnography to objectively assess sleep and slow-wave activity.
Post-sleep, participants will again complete a set of tasks and questionnaires assessing mood, sleepiness, cognition, and emotional processing. The primary tasks will include a modified AX-CPT task, an International Affective Picture Stimuli (IAPS) task, and the Karaoke task which will be competed in an fMRI scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The sleep techs who will score the sleep record and the fMRI personnel conducting the scanning sessions will also be masked.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Equal numbers of men and women will be included.
- •Normal hearing.
- •Elevated anxiety or depression symptoms. This will be determined using the PROMIS anxiety and PROMIS depression scales. Participants with T-scores ≥ 60 (i.e., ≥ than 1 standard deviation above the mean) on either or both scales will be eligible for participation.
- •Elevated sleep disturbance. This will be determined using the PROMIS sleep disturbance scale. Participants with T-scores ≥ 55 on the PROMIS sleep disturbance scale will be eligible for participation.
排除标准
- •Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder.
- •Current use of psychotropic medications or medications affecting sleep/wake function, such as antidepressants, antipsychotic medications, steroids, and stimulants. Rationale: These medications may affect sleep and cognitive-emotional function.
- •Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function.
- •Consumption of > 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function.
- •Consumption of > 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day.
- •Drug or alcohol use < 48 hours before the in-lab overnight sessions. Rationale: Recent drug or alcohol use could affect sleep, cognitive-emotional processes, and poses a safety risk.
- •Severe insomnia or sleep apnea symptoms. Insomnia symptoms will be determined using the Insomnia Severity Index. Participants with severe insomnia (i.e., scores > 21) will not be eligible. Sleep apnea symptoms will be determined using the STOP-Bang questionnaire. Participants with scores ≥ 3 will not be eligible. Rationale: Sleep disturbances which result in low sleep efficiency and frequent awakenings during the night may reduce the effectiveness of acoustic stimulation which targets the deepest stage of sleep (i.e., slow-wave sleep).
- •Extreme bedtimes (< 10:00pm, > 1:00am) or wake times (< 6:00am, > 10:00am). Rationale: Participants with extreme bed or wake times may have difficulty falling asleep, waking up, or obtaining a sufficient amount of sleep during the in-lab overnight sessions.
- •Short (<5hrs) or long (>9hrs) average sleep duration. Rationale: short or long sleepers may have different sleep profiles which could impact the effectiveness of the acoustic stimulation intervention.
- •Uncorrected vision problems.
- •Claustrophobia. Rationale: MRI safety criteria.
- •Metal in body. Rationale: MRI safety criteria.
- •Body Mass Index (BMI) >
- •Rationale: MRI safety criteria.
- •Pregnancy. Rationale: MRI safety criteria.
- •Left handedness. Rationale: Left-handed people may have different lateralization of neural functioning which could affect the fMRI results.
- •Formal vocal training. Rationale: The purpose of the karaoke task is to induce negative self-referential emotions via out-of-tune singing.
- •Does not own a smartphone or tablet. Rationale: Participants may need to download an app (SleepMapper or Alfin) to download their sleep data from the headband device when wearing it at home.
- •Inability or unwillingness to complete study procedures.
- •Hairstyles that prevent access to the scalp (e.g., weave). Rationale: Polysomnography for the in-lab overnights cannot be applied with hairstyles which prevent access to the scalp to apply electrodes.
结局指标
主要结局
Change in frontolimbic emotional reactivity circuit activity
时间窗: Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks
Change in fMRI activity in the frontolimbic emotional reactivity circuit activity for the negative v. neutral image contrast during the International Affective Picture Stimuli task
Acute change in slow-wave activity
时间窗: Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks
Change in 0.5 - 4 Hz delta spectral power
Change in cognitive flexibility d'
时间窗: Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition
Change in the standardized hit rate for BY trials minus the standardized false alarm rate to AX trials on the modified AX-CPT task
Slow-wave activity (chronic change)
时间窗: Assessed daily during the ~2 weeks at home
0.5 - 4 Hz delta spectral power
Change in top-down attention d'
时间窗: Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition
Change in the standardized hit rate for AX trials minus the standardized false alarm rate to AY trials on the modified AX-CPT task
Change in depression symptoms
时间窗: Change between four days; the screening visit, one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each
Change in self-reported depression using the PROMIS depression scale (T-scores range from 37.1-81.1, with higher scores indicating worse depression symptoms)
Change in negative affect
时间窗: Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition
Change in average self-reported negative affect using Likert-style scales during the International Affective Picture Stimuli task. Scales will range from 1-100, with higher scores representing more negative affect.
Change in anxiety symptoms
时间窗: Change between four days; the screening visit, one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each
Change in self-reported anxiety using the PROMIS anxiety scale (T-scores range from 36.3-82.7, with higher scores indicating worse anxiety symptoms)
Change in anxiety/depression symptoms
时间窗: Change across the ~2 weeks at home
Change in self-reported anxiety and depression using the Anxiety and Depression Scale (Both subscales will be assessed. Scores on each subscale range from 0-8, which higher scores indicating either more anxiety or more depression).
Change in mood
时间窗: Change across the ~2 weeks at home
Change in self-reported mood on the Daytime Insomnia Symptom Scale. All 20 subscales will be assessed and each subscale score ranges from 1-100, with higher scores indicating more of that mood (i.e., alert, sad, tense, effort, happy, weary, calm, sleep, overall mood, clear-headed, fatigued, anxious, exhausted, relaxed, forgetful, efficient, stressed, energetic, irritable, ability to concentrate).
Change in frontoparietal cognitive control circuit activity
时间窗: Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks
Change in fMRI activity in the frontoparietal cognitive control circuit activity (e.g., dorsolateral prefrontal cortex, inferior parietal lobule, middle cingulate gyrus, precuneus) for the AX v. AY contrast during the modified AX-CPT task
次要结局
- Change in self-referential affect(Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks)
- Frontolimbic emotional reactivity circuit activity(Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks)
- Acute change in slow-wave sleep (minutes)(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Chronic change in sleep efficiency(Change across the ~2 weeks at home)
- Chronic change in sleep latency(Change across the ~2 weeks at home)
- Chronic change in slow-wave sleep (minutes)(Change across the ~2 weeks at home)
- Chronic change in slow-wave sleep (%)(Change across the ~2 weeks at home)
- Acute change in sleep efficiency(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Chronic change in wake after sleep onset(Change across the ~2 weeks at home)
- Change in vigilant attention d'(Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition)
- Chronic change in total sleep time(Change across the ~2 weeks at home)
- Acute change in total sleep time(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Acute change in wake after sleep onset(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Acute change in slow-wave sleep (%)(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Acute change in sleep latency(Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks)
- Change in X-probe d'(Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition)
- Change in B-cue d'(Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition)
- Change in Y-probe d'(Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition)
研究者
Michelle Stepan
Assistant Professor
University of Pittsburgh