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Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms

ClinicalTrials.gov IDNCT05802004

PhaseNA

Enrollment40

SponsorMichelle Stepan

Age18 Years

SexALL

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Conditions studied

Acoustic Stimulation

About this study

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.

Interventions

Device: Acoustic Stimulation (STIM) — 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).
Device: No Acoustic Stimulation (SHAM) — 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.
Device: Daily acoustic stimulation (STIM2) — 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).
Device: No daily acoustic stimulation (SHAM2) — 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.

Primary outcomes

Acute change in slow-wave activity (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) (Assessed daily during the ~2 weeks at home)
Change in top-down 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)
Change in cognitive flexibility 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 frontoparietal cognitive control 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)
Change in frontoparietal cognitive control 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)
Change in 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 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)

Eligibility information

Inclusion Criteria: 1. Age 18-25. Equal numbers of men and women will be included. 2. Normal hearing. 3. 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. 4. 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. Exclusion Criteria: 1. Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder. 2. 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. 3. Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function. 4. Consumption of \&gt; 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function. 5. Consumption of \&gt; 400mg of caffeine per day, which is roughly equivalent to 3-4 8oz cups of coffee per day. 6. Drug or alcohol use \&lt; 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. 7. Severe insomnia or sleep apnea symptoms. Insomnia symptoms will be determined using the Insomnia Severity Index. Participants with severe insomnia (i.e., scores \&gt; 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). 8. Extreme bedtimes (\&lt; 10:00pm, \&gt; 1:00am) or wake times (\&lt; 6:00am, \&gt; 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. 9. Short (\&lt;5hrs) or long (\&gt;9hrs) average sleep duration. Rationale: short or long sleepers may have different sleep profiles which could impact the effectiveness of the acoustic stimulation intervention. 10. Uncorrected vision problems. 11. Claustrophobia. Rationale: MRI safety criteria. 12. Metal in body. Rationale: MRI safety criteria. 13. Body Mass Index (BMI) \&gt; 40. Rationale: MRI safety criteria. 14. Pregnancy. Rationale: MRI safety criteria. 15. Left handedness. Rationale: Left-handed people may have different lateralization of neural functioning which could affect the fMRI results. 16. 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. 17. 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. 18. Inability or unwillingness to complete study procedures. 19. 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.

Study locations

University of Pittsburgh, Pittsburgh, Pennsylvania 15213 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.