Actively Recruiting

Phase Not Applicable
Age: 18Years - 25Years
All Genders
NCT05802004

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

Led by Michelle Stepan · Updated on 2025-09-18

40

Participants Needed

1

Research Sites

148 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 25 years, with equal numbers of men and women included
  • Normal hearing
  • Elevated anxiety or depression symptoms as measured by PROMIS scales with T-scores ≥ 60
  • Elevated sleep disturbance with PROMIS sleep disturbance T-score ≥ 55
Not Eligible

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, or stimulants
  • Substance abuse
  • Consuming more than 14 alcoholic drinks per week
  • Consuming more than 400 mg of caffeine daily
  • Drug or alcohol use within 48 hours before in-lab overnight sessions
  • Severe insomnia (Insomnia Severity Index score > 21) or sleep apnea risk (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 (BMI) greater than 40
  • Pregnancy
  • Left-handedness
  • Formal vocal training or good/very good singing ability
  • Does not own a smartphone or tablet
  • Unable or unwilling to complete study procedures
  • Hairstyles that prevent scalp access for electrode placement (e.g., weave)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

M

Michelle E Stepan, PhD

CONTACT

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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