Health TrialsbyHealthPanel

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

ConditionAcoustic Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMichelle Stepan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-25. Equal numbers of men and women will be included.

Normal hearing.

Elevated anxiety or depression symptoms. This will be determined using the PROMIS anxiety and PROMIS depression scales. Participants with T-scores ≥ 60 (i.e., ≥ than 1 standard deviation above the mean) on either or both scales will be eligible for participation.

Elevated sleep disturbance. This will be determined using the PROMIS sleep disturbance scale. Participants with T-scores ≥ 55 on the PROMIS sleep disturbance scale will be eligible for participation.

Disqualifiers

Presence of a severe chronic or psychiatric condition including psychosis, bipolar disorder, developmental disorders, or substance use disorder.

Current use of psychotropic medications or medications affecting sleep/wake function, such as antidepressants, antipsychotic medications, steroids, and stimulants. Rationale: These medications may affect sleep and cognitive-emotional function.

Substance abuse. Rationale: Substance abuse may affect sleep and cognitive-emotional function.

Consumption of > 14 standard alcoholic drinks per week. Rationale: excessive alcohol consumption may interfere with sleep and cognitive-emotional function.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Stim, then Sham, then daily StimExperimental treatment 3 interventions
Group B: Stim, then Sham, then daily ShamExperimental treatment 3 interventions
Group C: Sham, then Stim, then daily StimExperimental treatment 3 interventions
Group D: Sham, then Stim, then daily ShamExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Acute change in slow-wave activity

Change in 0.5 - 4 Hz delta spectral power

Time frame
Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks
2

Slow-wave activity (chronic change)

0.5 - 4 Hz delta spectral power

Time frame
Assessed daily during the ~2 weeks at home
3

Change in top-down attention d'

Change in the standardized hit rate for AX trials minus the standardized false alarm rate to AY trials on the modified AX-CPT task

Time frame
Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition
4

Change in cognitive flexibility d'

Change in the standardized hit rate for BY trials minus the standardized false alarm rate to AX trials on the modified AX-CPT task

Time frame
Change between three days; one following a night in the Sham condition, one following a night in the Stim condition, and one following either the Sham2 or Stim2 condition; with ~1-2 weeks between each condition

Secondary outcomes

1

Change in self-referential affect

Average self-reported emotion intensity using Likert-style scales ranging from 1-5 during the Karaoke task, in which higher scores represent greater emotional intensity.

Time frame
Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks
2

Frontolimbic emotional reactivity circuit activity

fMRI activity in the frontolimbic emotional reactivity circuit activity for the own-singing v. professional-singing contrast during the Karaoke task

Time frame
Change between two days, one following a night in the Sham condition and one following a night in the Stim condition, separated by ~1-2 weeks
3

Acute change in slow-wave sleep (minutes)

Change in minutes of time in slow-wave sleep

Time frame
Change between two nights, one night in the Sham condition and one night in the Stim condition, separated by ~1-2 weeks
4

Chronic change in slow-wave sleep (minutes)

Change in minutes of time in slow-wave sleep

Time frame
Change across the ~2 weeks at home

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michelle Stepan

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

Brain & Behavior Research Foundation

Collaborator

Source ClinicalTrials.gov
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