Acoustic StimulationSERSNCT05802004
Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms
A study testing Acoustic Stimulation (STIM) and Daily acoustic stimulation (STIM2) in people with Acoustic Stimulation, run by Michelle Stepan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Acoustic Stimulation
- What is being tested?
- Acoustic Stimulation (STIM) and Daily acoustic stimulation (STIM2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Formal vocal training and Good/Very Good at singing in tune. 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Michelle E Stepan, PhD, 7247570761, stepanme@upmc.edu
About this study
Official title: The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms
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.
Read the detailed description
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.
After a 1-2-week washout period at home, participants will return for their second overnight session to complete the other experimental condition. For at least one week before the second overnight, participants will maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes), verified with wrist actigraphy and sleep diary. Participants will again be asked to refrain from alcohol and recreational drugs use for 48hrs before the overnight session and will be asked to refrain from consuming caffeine after Noon on the day of their overnight visit. Participants will again be asked to wear the headband device at home for one night prior to their overnight visit.
After completing the second overnight session, participants will take a headband device home and wear it each night for approximately 2 weeks. Participants will be asked to maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes). Half of the participants will be randomly assigned to receive tones each night (Stim2) and half will not (Sham2). Participant will be blind to condition. Participants will complete daily assessments of their mood, anxiety/depression symptoms, and sleep quality. After the ~2 weeks at home, participants will return for a final testing visit. Participants will complete assessments of their mood, anxiety/depression symptoms, cognition, and emotional processing.
Below is a description of the primary tasks:
AX-CPT task: participants view cue-probe pairings, displayed as two letters presented one at a time on a computer screen. The first letter is the cue and the second letter is the probe. Participants are instructed to press a button when they encounter the valid cue-probe pairing and a different button for non-valid cue-probe pairings.
IAPS task: participants will be presented with neutral and negative images from the International Affective Picture System. Participants may be asked to rate their affect, valence, and arousal after each image.
Karaoke task: this task is intended to assess emotional processes, particularly self-referential emotions (i.e., shame, embarrassment). During the baseline visit, participants will sing while being audio recorded. Participants may be asked to wear headphones, which will present the song audio, but will mask their own singing, to promote out-of-tune singing. During the overnight visits, participants will listen to audio snips of their own singing and the same song sung by a professional singer. Participants will rate the intensity of different emotions.
- Conditions
- Acoustic Stimulation
- Being tested
- Acoustic Stimulation (STIM), No Acoustic Stimulation (SHAM), Daily acoustic stimulation (STIM2), No daily acoustic stimulation (SHAM2)
- Keywords
- Acoustic stimulation, Slow-wave activity, Anxiety, Depression, Cognitive control, Emotion, Daily acoustic stimulation
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Stimulation (STIM)Device
Also called Philips SmartSleep Deep Sleep Headband, Dreem 2 Headband
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).
No Acoustic Stimulation (SHAM)Device
Also called Philips SmartSleep Deep Sleep Headband, Dreem 2 Headband
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.
Daily acoustic stimulation (STIM2)Device
Also called Philips SmartSleep Deep Sleep Headband, Dreem 2 Headband
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).
No daily acoustic stimulation (SHAM2)Device
Also called Philips SmartSleep Deep Sleep Headband, Dreem 2 Headband
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.
| Study group | Role | What they receive |
|---|---|---|
| Stim, then Sham, then daily Stim | Experimental | For 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. Receives: Device: Acoustic Stimulation (STIM); Device: No Acoustic Stimulation (SHAM); Device: Daily acoustic stimulation (STIM2) |
| Stim, then Sham, then daily Sham | Experimental | For 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. Receives: Device: Acoustic Stimulation (STIM); Device: No Acoustic Stimulation (SHAM); Device: No daily acoustic stimulation (SHAM2) |
| Sham, then Stim, then daily Stim | Experimental | For 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. Receives: Device: Acoustic Stimulation (STIM); Device: No Acoustic Stimulation (SHAM); Device: Daily acoustic stimulation (STIM2) |
| Sham, then Stim, then daily Sham | Experimental | For 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. Receives: Device: Acoustic Stimulation (STIM); Device: No Acoustic Stimulation (SHAM); Device: No daily acoustic stimulation (SHAM2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute change in slow-wave activity
Change in 0.5 - 4 Hz delta spectral power
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Change across the ~2 weeks at home
Secondary outcomes (18)
Change in self-referential affect
Average self-reported emotion intensity using Likert-style scales ranging from 1-5 during the Karaoke task, in which higher scores represent greater emotional intensity.
Measured: 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
fMRI activity in the frontolimbic emotional reactivity circuit activity for the own-singing v. professional-singing contrast during the Karaoke task
Measured: 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 in minutes of time in slow-wave sleep
Measured: 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 in minutes of time in slow-wave sleep
Measured: Change across the ~2 weeks at home
Acute change in slow-wave sleep (%)
Change in percent of time in slow-wave sleep
Measured: 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 (%)
Change in percent of time in slow-wave sleep
Measured: Change across the ~2 weeks at home
Acute change in total sleep time
Change in minutes asleep
Measured: 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 total sleep time
Change in minutes asleep
Measured: Change across the ~2 weeks at home
Acute change in sleep efficiency
Change in proportion of time in bed spent asleep
Measured: 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 in proportion of time in bed spent asleep
Measured: Change across the ~2 weeks at home
Acute change in wake after sleep onset
Change in minutes awake after sleep onset
Measured: 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 in minutes awake after sleep onset
Measured: Change across the ~2 weeks at home
Acute change in sleep latency
Change in minutes until sleep onset
Measured: 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 latency
Change in minutes until sleep onset
Measured: Change across the ~2 weeks at home
Change in X-probe d'
Change in the standardized hit rate for AX trials minus the standardized false alarm rate to BX trials on the modified AX-CPT task
Measured: 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 in the standardized hit rate for BY trials minus the standardized false alarm rate to AX trials on the modified AX-CPT task
Measured: 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 in the standardized hit rate for BY trials minus the standardized false alarm rate to AY trials on the modified AX-CPT task
Measured: 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 vigilant attention d'
Change in the standardized hit rate for AX trials minus the standardized false alarm rate to CD trials on the modified AX-CPT task
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start24 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acoustic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, within-subjects, crossover design with two conditions: acoustic stimulation (STIM) and no acoustic stimulation (SHAM), followed by an at-home randomized, between-subjects design with two conditions: daily acoustic stimulation (STIM2) or no daily acoustic stimulation (SHAM2).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Stepan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brain & Behavior Research Foundation
- Responsible party
- Sponsor-investigator, Michelle Stepan, University of Pittsburgh
- Investigators
- Michelle E Stepan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802004
- Sponsor's protocol ID
- STUDY22040183
- Other IDs
- K01MH130502, NARSAD Young Investigator
- Acronym
- SERS
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms
- ClinicalTrials.gov ID
- NCT05802004
- Acronym / sponsor ID
- SERS / STUDY22040183
- Conditions
- Acoustic Stimulation
- Keywords
- Acoustic stimulation, Slow-wave activity, Anxiety, Depression, Cognitive control, Emotion, Daily acoustic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Michelle StepanUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brain & Behavior Research Foundation
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
After a 1-2-week washout period at home, participants will return for their second overnight session to complete the other experimental condition. For at least one week before the second overnight, participants will maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes), verified with wrist actigraphy and sleep diary. Participants will again be asked to refrain from alcohol and recreational drugs use for 48hrs before the overnight session and will be asked to refrain from consuming caffeine after Noon on the day of their overnight visit. Participants will again be asked to wear the headband device at home for one night prior to their overnight visit.
After completing the second overnight session, participants will take a headband device home and wear it each night for approximately 2 weeks. Participants will be asked to maintain a consistent sleep schedule (+/- 1hr around wake and bedtimes). Half of the participants will be randomly assigned to receive tones each night (Stim2) and half will not (Sham2). Participant will be blind to condition. Participants will complete daily assessments of their mood, anxiety/depression symptoms, and sleep quality. After the ~2 weeks at home, participants will return for a final testing visit. Participants will complete assessments of their mood, anxiety/depression symptoms, cognition, and emotional processing.
Below is a description of the primary tasks:
AX-CPT task: participants view cue-probe pairings, displayed as two letters presented one at a time on a computer screen. The first letter is the cue and the second letter is the probe. Participants are instructed to press a button when they encounter the valid cue-probe pairing and a different button for non-valid cue-probe pairings.
IAPS task: participants will be presented with neutral and negative images from the International Affective Picture System. Participants may be asked to rate their affect, valence, and arousal after each image.
Karaoke task: this task is intended to assess emotional processes, particularly self-referential emotions (i.e., shame, embarrassment). During the baseline visit, participants will sing while being audio recorded. Participants may be asked to wear headphones, which will present the song audio, but will mask their own singing, to promote out-of-tune singing. During the overnight visits, participants will listen to audio snips of their own singing and the same song sung by a professional singer. Participants will rate the intensity of different emotions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This is a randomized, within-subjects, crossover design with two conditions: acoustic stimulation (STIM) and no acoustic stimulation (SHAM), followed by an at-home randomized, between-subjects design with two conditions: daily acoustic stimulation (STIM2) or no daily acoustic stimulation (SHAM2).
| Arm | Type | Receives |
|---|---|---|
| Stim, then Sham, then daily Stim | Experimental | Device: Acoustic Stimulation (STIM), Device: No Acoustic Stimulation (SHAM), Device: Daily acoustic stimulation (STIM2)For 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 | Experimental | Device: Acoustic Stimulation (STIM), Device: No Acoustic Stimulation (SHAM), Device: No daily acoustic stimulation (SHAM2)For 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 | Experimental | Device: Acoustic Stimulation (STIM), Device: No Acoustic Stimulation (SHAM), Device: Daily acoustic stimulation (STIM2)For 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 | Experimental | Device: Acoustic Stimulation (STIM), Device: No Acoustic Stimulation (SHAM), Device: No daily acoustic stimulation (SHAM2)For 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic Stimulation (STIM)Also: Philips SmartSleep Deep Sleep Headband, Dreem 2 HeadbandDuring 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). | Device | Sham, then Stim, then daily Sham, Sham, then Stim, then daily Stim, Stim, then Sham, then daily Sham, Stim, then Sham, then daily Stim |
| No Acoustic Stimulation (SHAM)Also: Philips SmartSleep Deep Sleep Headband, Dreem 2 HeadbandDuring 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. | Device | Sham, then Stim, then daily Sham, Sham, then Stim, then daily Stim, Stim, then Sham, then daily Sham, Stim, then Sham, then daily Stim |
| Daily acoustic stimulation (STIM2)Also: Philips SmartSleep Deep Sleep Headband, Dreem 2 HeadbandDuring 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). | Device | Sham, then Stim, then daily Stim, Stim, then Sham, then daily Stim |
| No daily acoustic stimulation (SHAM2)Also: Philips SmartSleep Deep Sleep Headband, Dreem 2 HeadbandDuring 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. | Device | Sham, then Stim, then daily Sham, Stim, then Sham, then daily Sham |
Primary outcome
Acute change in slow-wave activity
Time frame: 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
Slow-wave activity (chronic change)
Time frame: Assessed daily during the ~2 weeks at home
0.5 - 4 Hz delta spectral power
Change in top-down attention d'
Time frame: 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 cognitive flexibility d'
Time frame: 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
Change in frontoparietal cognitive control circuit activity
Time frame: 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
Change in frontoparietal cognitive control circuit activity
Time frame: 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 BY v. AX contrast during the modified AX-CPT task
Change in negative affect
Time frame: 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 frontolimbic emotional reactivity circuit activity
Time frame: 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
Change in anxiety symptoms
Time frame: 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 depression symptoms
Time frame: 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 mood
Time frame: 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 anxiety/depression symptoms
Time frame: 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).
18 secondary outcomes
Change in self-referential affect
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Change across the ~2 weeks at home
Acute change in slow-wave sleep (%)
Time frame: 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 (%)
Time frame: Change across the ~2 weeks at home
Acute change in total sleep time
Time frame: 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 total sleep time
Time frame: Change across the ~2 weeks at home
Acute change in sleep efficiency
Time frame: 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
Time frame: Change across the ~2 weeks at home
Acute change in wake after sleep onset
Time frame: 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
Time frame: Change across the ~2 weeks at home
Acute change in sleep latency
Time frame: 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 latency
Time frame: Change across the ~2 weeks at home
Change in X-probe d'
Time frame: 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'
Time frame: 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'
Time frame: 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 vigilant attention d'
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle E Stepan, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic Stimulation (STIM) and Daily acoustic stimulation (STIM2) in people with Acoustic Stimulation, run by Michelle Stepan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle E Stepan, PhD (7247570761, stepanme@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in slow-wave activity (time frame: Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.