Actively Recruiting
The Effect of Acoustic Enhancement of Slow-Wave Activity on Cognitive Control and Emotional Reactivity in Young Adults With Anxiety and Depression Symptoms
Led by Michelle Stepan · Updated on 2025-09-18
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Michelle Stepan
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying young adults aged 18 to 25 with elevated anxiety or depression symptoms and sleep disturbances. This study evaluates how acoustic stimulation during slow-wave sleep affects cognitive control and emotional responses. The trial uses devices to enhance slow-wave activity during sleep and measures behavioral, self-reported, and brain imaging outcomes to understand the impact on mood and cognition. Participants complete two overnight sessions in a sleep lab wearing a headband device that either plays sub-arousal tones during slow-wave sleep or does not. The order of these sessions is randomized. After these visits, participants use the headband device at home nightly for about two weeks, with half receiving the tones and half not, to assess longer-term effects. Throughout the study, participants undergo cognitive and emotional assessments including tasks like the AX-CPT, IAPS, and karaoke tasks, along with mood and sleep diaries. Researchers collect sleep data using polysomnography and actigraphy. Final evaluations happen after the home use period to measure changes in anxiety, depression symptoms, cognitive flexibility, and brain activity related to emotional and cognitive processes.
CONDITIONS
Brief Title
Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults With Anxiety and Depression Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 25 years
- Equal numbers of men and women will be included
- Normal hearing
- Elevated anxiety or depression symptoms with PROMIS T-scores ≥ 60
- Elevated sleep disturbance with PROMIS sleep disturbance T-scores ≥ 55
You will not qualify if you...
- Severe chronic or psychiatric conditions such as psychosis, bipolar disorder, developmental disorders, or substance use disorder
- Current use of psychotropic or sleep-affecting medications including antidepressants, antipsychotics, steroids, and stimulants
- Substance abuse
- Consumption of more than 14 standard alcoholic drinks per week
- Consumption of more than 400mg of caffeine per day
- Drug or alcohol use within 48 hours before overnight sessions
- Severe insomnia (Insomnia Severity Index > 21) or sleep apnea symptoms (STOP-Bang score ≥ 3)
- Extreme bedtimes (before 10:00pm or after 1:00am) or wake times (before 6:00am or after 10:00am)
- Average sleep duration less than 5 hours or more than 9 hours
- Uncorrected vision problems
- Claustrophobia
- Metal in the body
- Body Mass Index over 40
- Pregnancy
- Left handedness
- Formal vocal training or good/very good singing ability
- Lack of smartphone or tablet ownership
- Inability or unwillingness to complete study procedures
- Hairstyles that prevent scalp access for polysomnography electrodes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 online screening survey and 1 in-person baseline visit
Duration - About 1 week before each overnight session
Participants provide informed consent, undergo additional screening, hearing test, and audio recording. They are given a wrist actigraphy device and complete a daily electronic sleep diary at home for approximately 1 week before each overnight session to maintain a consistent sleep schedule. Participants also wear the headband device for one night at home to acclimate before overnight visits.
1 in-person baseline visit and home monitoring
Duration - 2 overnight visits spaced ~1-2 weeks apart
Participants complete two overnight visits in the sleep lab, spaced approximately 1-2 weeks apart. Before each overnight, they follow sleep and substance use restrictions. During each overnight, participants complete tasks and questionnaires assessing mood, sleepiness, cognition, and emotional processing before and after sleep. They wear a headband device with either acoustic stimulation (STIM) or no stimulation (SHAM) in randomized order while polysomnography monitors sleep.
2 overnight in-person visits
Duration - Approximately 2 weeks
After the in-lab sessions, participants take the headband device home and wear it nightly for approximately 2 weeks. Half of the participants receive acoustic stimulation each night, and half do not, remaining blind to condition. Participants complete daily assessments of mood, anxiety/depression symptoms, and sleep quality while maintaining a consistent sleep schedule.
Daily use at home with daily assessments
Duration - 1 visit
Participants return for a final in-person visit to complete assessments of mood, anxiety/depression symptoms, cognition, and emotional processing following the at-home headband use period.
1 in-person visit
Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
M
Michelle E Stepan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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