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Acoustic StimulationSleepCognitive functionDigital healthMental healthDevice

What this study is

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.

What's being tested

  • Acoustic Stimulation (STIM)

    Intervention · DEVICE

    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)

    Intervention · DEVICE

    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)

    Intervention · DEVICE

    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)

    Intervention · DEVICE

    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 details

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
Sponsor
Michelle Stepan
Conditions
Acoustic Stimulation
Enrolling
40 people
Starts
2024-04-24
Est. completion
2027-03
Design
Single-blind, randomized, crossover
Record
View on ClinicalTrials.gov ↗