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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
SERS Trial 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.Check my eligibility
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.See study design
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.
SERS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between two nights, one night in the sham condition and one night in the stim condition, separated by ~1-2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between two nights, one night in the sham condition and one night in the stim condition, separated by ~1-2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute change in slow-wave activity
Change in anxiety symptoms
Change in anxiety/depression symptoms
+8 moreSecondary outcome measures
Acute change in sleep efficiency
Acute change in sleep latency
Acute change in slow-wave sleep (%)
+15 moreSERS 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.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,343,116 Total Patients Enrolled
Michelle StepanLead Sponsor
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,669 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe insomnia or symptoms of sleep apnea.I can sing in tune well.I am currently taking medication for my mental health or sleep.I have undergone formal vocal training.I am unable or unwilling to follow the study's procedures.I am between 18 and 25 years old.I have normal hearing.My sleep quality is poor, scoring 55 or higher on a sleep test.
Research Study Groups:
This trial has the following groups:- Group 1: Stim, then Sham, then daily Stim
- Group 2: Stim, then Sham, then daily Sham
- Group 3: Sham, then Stim, then daily Stim
- Group 4: Sham, then Stim, then daily Sham
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this trial open to individuals over 45 years of age?
"This clinical trial requires participants to be between 18 and 25 years old, in accordance with the specified age range set forth as inclusion criteria."
Answered by AI
Are there available vacancies in this research endeavor?
"Based on the information posted to clinicaltrials.gov, this study is not currently seeking participants; it was initially launched on April 1st 2023 and last edited 24th March 2023. Fortunately, there are 1169 other trials that remain open for patient recruitment."
Answered by AI
Who is qualified to participate in this clinical investigation?
"The prerequisites for this trial include exposure to acoustic stimulation and an age between 18 and 25 years old. All in all, 40 individuals will be chosen as participants."
Answered by AI
What is the major goal of this experiment?
"This study's primary objective is to observe the chronic variation in slow-wave activity resulting from a shift between sham and stimulation overnight. Secondary outcomes encompass fMRI scans of frontolimbic emotional reactivity during karaoke, as well as an assessment of acute and chronic changes in minutes spent in slow-wave sleep."
Answered by AI
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