Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms
SERS
The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms
3 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 18, 2025
September 1, 2025
2.9 years
March 13, 2023
September 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Acute change in slow-wave activity
Change in 0.5 - 4 Hz delta spectral power
Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks
Slow-wave activity (chronic change)
0.5 - 4 Hz delta spectral power
Assessed daily during the ~2 weeks at home
Change in top-down attention d'
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 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 cognitive flexibility d'
Change in the standardized hit rate for BY trials minus the standardized false alarm rate to AX trials on the modified AX-CPT task
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 frontoparietal cognitive control circuit activity
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
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 frontoparietal cognitive control circuit activity
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 BY v. AX contrast during the modified AX-CPT task
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 negative affect
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 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 frontolimbic emotional reactivity circuit activity
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
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 anxiety symptoms
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 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 depression symptoms
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 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 mood
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 across the ~2 weeks at home
Change in anxiety/depression symptoms
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 across the ~2 weeks at home
Secondary Outcomes (18)
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 slow-wave sleep (minutes)
Change across the ~2 weeks at home
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
- +13 more secondary outcomes
Study Arms (4)
Stim, then Sham, then daily Stim
EXPERIMENTALFor the 2 overnights in the sleep lab, this arm will be randomized to complete acoustic stimulation (STIM) on the first overnight and no acoustic stimulation (SHAM) on the second overnight and then daily acoustic stimulation (STIM2) during the \~2 weeks at-home.
Stim, then Sham, then daily Sham
EXPERIMENTALFor the 2 overnights in the sleep lab, this arm will be randomized to complete acoustic stimulation (STIM) on the first overnight and no acoustic stimulation (SHAM) on the second overnight and then no daily acoustic stimulation (SHAM2) during the \~2 weeks at-home.
Sham, then Stim, then daily Stim
EXPERIMENTALFor the 2 overnights in the sleep lab, this arm will be randomized to complete no acoustic stimulation (SHAM) on the first overnight and acoustic stimulation (STIM) on the second overnight and then daily acoustic stimulation (STIM2) during the \~2 weeks at-home.
Sham, then Stim, then daily Sham
EXPERIMENTALFor the 2 overnights in the sleep lab, this arm will be randomized to complete no acoustic stimulation (SHAM) on the first overnight and acoustic stimulation (STIM) on the second overnight and then no daily acoustic stimulation (SHAM2) during the \~2 weeks at-home.
Interventions
During the in-lab overnight, a headband device will be used to administer acoustic stimulation. Tones will be played during slow-wave sleep to enhance underlying slow-wave activity (0.5 - 4 Hz delta spectral power).
During the in-lab overnight, the participant will wear a headband device, but the device will not administer acoustic stimulation. The device will be on and will still monitor sleep, but will not play tones.
During the \~2 weeks at home, a headband device will be used to administer acoustic stimulation. Tones will be played during slow-wave sleep to enhance underlying slow-wave activity (0.5 - 4 Hz delta spectral power).
During the \~2 weeks at home, the participant will wear a headband device, but the device will not administer acoustic stimulation. The device will be on and will still monitor sleep, but will not play tones.
Eligibility Criteria
You may qualify if:
- Age 18-25. 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.
You may not qualify if:
- 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) \> 40. 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michelle Stepanlead
- National Institute of Mental Health (NIMH)collaborator
- Brain & Behavior Research Foundationcollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle E Stepan, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The sleep techs who will score the sleep record and the fMRI personnel conducting the scanning sessions will also be masked.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 13, 2023
First Posted
April 6, 2023
Study Start
April 24, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available once data collection is finalized. IPD associated with manuscripts will become available once the manuscript is published.
- Access Criteria
- To access the data, the requester must have completed and up-to-date research and ethics training and data use or material transfer agreements must be in place.
De-identified IPD associated with publications will be made available to researchers upon reasonable request. IPD will also be stored in a central data repository at the University of Pittsburgh, which can be accessed by researchers at the institution who have appropriate qualifications and access information. Examples of IPD that can be shared with other researchers include descriptive data such as means and de-identified performance scores on cognitive and emotional tasks, self-reports of mood or anxiety/depression symptoms, summarized sleep EEG data, and summarized fMRI data.