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

Conditions

• Acoustic Stimulation

Eligibility Criteria

Sex

ALL

Age

18 Years - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Acoustic Stimulation (STIM) — 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) — 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) — 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) — 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

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.

Key Dates

Start date

Apr 24, 2024

Status verified

Sep 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Stim, then Sham, then daily Stim
  For the 2 overnights in the sleep lab, this arm will be randomized to complete acoustic stimulation (STIM) on the first overnight and no acoustic stimulation (SHAM) on the second overnight and then daily acoustic stimulation (STIM2) during the \~2 weeks at-home.
• Experimental: Stim, then Sham, then daily Sham
  For the 2 overnights in the sleep lab, this arm will be randomized to complete acoustic stimulation (STIM) on the first overnight and no acoustic stimulation (SHAM) on the second overnight and then no daily acoustic stimulation (SHAM2) during the \~2 weeks at-home.
• Experimental: Sham, then Stim, then daily Stim
  For the 2 overnights in the sleep lab, this arm will be randomized to complete no acoustic stimulation (SHAM) on the first overnight and acoustic stimulation (STIM) on the second overnight and then daily acoustic stimulation (STIM2) during the \~2 weeks at-home.
• Experimental: Sham, then Stim, then daily Sham
  For the 2 overnights in the sleep lab, this arm will be randomized to complete no acoustic stimulation (SHAM) on the first overnight and acoustic stimulation (STIM) on the second overnight and then no daily acoustic stimulation (SHAM2) during the \~2 weeks at-home.

Primary Outcome Measure

Acute change in slow-wave activity [ Time Frame: Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks ]

Central Contacts

• Michelle E Stepan, PhD
  7247570761
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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• Acoustic Stimulation During Restricted Sleep After Sleep Deprivation
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