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

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.

Conditions

• Acoustic Stimulation

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Brain & Behavior Research Foundation

  collaborator OTHER

• Michelle Stepan

  lead OTHER

Principal Investigators

• Michelle E Stepan, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-24

Primary Completion

2027-03-31

Completion

2027-03-31

FDA Device

Yes

Countries

• United States

Study Locations