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Acoustic Stimulation for Depression (SERS Trial)

N/A

Recruiting

Led By Michelle E Stepan, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how tones delivered during sleep can affect young adults' anxiety/depression symptoms & sleep disturbance. It'll include overnight stays in a sleep lab & home use of a headband device. Cognitive & emotional processes will be evaluated.

Who is the study for?

Young adults aged 18-25 with normal hearing, experiencing anxiety or depression and sleep disturbances can join. They must not use drugs/alcohol before sessions, have extreme sleep schedules, vision issues, claustrophobia, metal in the body, a BMI over 40, severe insomnia/sleep apnea symptoms or be pregnant.

What is being tested?

The trial tests if acoustic stimulation during sleep affects cognitive-emotional processes in those with anxiety/depression. Participants wear a headband at night that may play tones to enhance slow-wave activity; effects are measured through tasks and self-reports.

What are the potential side effects?

There might be minimal side effects from wearing the Dreem 2 Headband device for acoustic stimulation. However, discomfort due to wearing the device overnight could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute change in slow-wave activity

Change in anxiety symptoms

Change in anxiety/depression symptoms

+8 more

Secondary study objectives

Acute change in sleep efficiency

Acute change in sleep latency

Acute change in slow-wave sleep (%)

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stim, then Sham, then daily StimExperimental Treatment3 Interventions

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.

Group II: Stim, then Sham, then daily ShamExperimental Treatment3 Interventions

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.

Group III: Sham, then Stim, then daily StimExperimental Treatment3 Interventions

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.

Group IV: Sham, then Stim, then daily ShamExperimental Treatment3 Interventions

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.

Do I qualify?Apply below to find out