Acoustic Stimulation for Depression
(SERS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Must not be taking: Antidepressants, Antipsychotics, Steroids, Stimulants
Disqualifiers: Psychosis, Bipolar, Substance use, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any psychotropic medications or medications affecting sleep/wake function, such as antidepressants, antipsychotic medications, steroids, and stimulants, as these may affect sleep and cognitive-emotional function.
What data supports the effectiveness of the treatment Acoustic Stimulation for Depression?
Research shows that auditory stimulation can increase REM sleep time and improve sleep efficiency in healthy individuals, which might suggest potential benefits for mood regulation. However, in depressed patients, auditory stimulation did not lead to clinical improvements, indicating that its effectiveness for depression specifically is not supported by current evidence.
12345Is acoustic stimulation generally safe for humans?
The research does not provide specific safety data for acoustic stimulation in humans for depression, but studies on similar treatments like Electric-Acoustic Stimulation (EAS) in adults with hearing loss suggest it is generally safe.
46789How does acoustic stimulation treatment for depression differ from other treatments?
Acoustic stimulation for depression is unique because it uses sound therapy to potentially influence sleep patterns and neural processes, unlike standard treatments like medication or therapy. This non-invasive approach aims to enhance sleep efficiency and memory processing, offering a novel alternative without the side effects associated with drugs.
1251011Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 25 years old.
Elevated anxiety or depression symptoms determined using the PROMIS anxiety and PROMIS depression scales with T-scores ≥ 60
I have normal hearing.
+1 more
Exclusion Criteria
Short (<5hrs) or long (>9hrs) average sleep duration
Substance abuse
I have severe insomnia or symptoms of sleep apnea.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Online survey and in-person baseline visit
Baseline and Acclimation
Participants complete baseline assessments and acclimate to the headband device
1 week
1 in-person visit, daily sleep diary entries
Overnight Sessions
Participants undergo two overnight sessions with acoustic stimulation and sham conditions
2 weeks
2 overnight visits
At-home Phase
Participants use the headband device at home for approximately 2 weeks with daily assessments
2 weeks
Daily at-home use and assessments
Follow-up
Participants return for a final testing visit to assess cognitive and emotional processes
1 day
1 in-person visit
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
Michelle StepanLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
Brain & Behavior Research FoundationCollaborator
References
Effects of auditory stimulation during rapid eye movement sleep in healthy volunteers and depressed patients. [2019]Auditory and somesthesic forms of stimulation have substantially increased rapid eye movement (REM) sleep in cats. We investigated whether auditory stimulation, applied during REM sleep or outside REM sleep, would have similar effects in normal volunteers. We also administered auditory stimulation to depressed patients during REM sleep. Subjects were studied during 1 acclimatization night, 2 baseline nights, 4 consecutive nights with auditory stimulation, and 1 followup night without auditory stimulation. Normal volunteers were randomly divided into Group R, which received auditory stimulation during each REM sleep episode, and Group NR, which received auditory stimulation at the end of each REM sleep episode. Depressed patients (Group D) received auditory stimulation during each REM sleep period. Only Group R showed increased REM sleep time during the nights of auditory stimulation and throughout the followup night. This group also increased their sleep efficiency. Group NR showed reduced sleep efficiency due to an increase in both the duration and frequency of awakenings. Group D did not show increased REM sleep time, but did show shortened REM sleep episodes, increased REM sleep frequency, and increased duration of awakenings. Group D did not show clinical changes.
Sounding It Out: Auditory Stimulation and Overnight Memory Processing. [2022]Auditory stimulation is a technique that can enhance neural oscillations linked to overnight memory consolidation. In this review, we evaluate the impacts of auditory stimulation on the neural oscillations of sleep and associated memory processes in a variety of populations.
Updated Review of the Acoustic Modulation of Sleep: Current Perspectives and Emerging Concepts. [2021]With growing interest in the use of acoustic stimuli in sleep research and acoustic interventions used therapeutically for sleep enhancement, there is a need for an overview of the current lines of research. This paper summarizes the various ways to use acoustic input before sleep or stimulation during sleep. It thereby focuses on the respective methodological requirements, advantages, disadvantages, potentials and difficulties of acoustic sleep modulation. It highlights differences in subjective and objective outcome measures, immediate and whole night effects and short versus long term effects. This recognizes the fact that not all outcome parameters are relevant in every research field. The same applies to conclusions drawn from other outcome dimensions, consideration of mediating factors, levels of stimulation processing and the impact of inter-individual differences. In addition to the deliberate influences of acoustic input on sleep, one paragraph describes adverse environmental acoustic influences. Finally, the possibilities for clinical and basic research-related applications are discussed, and emerging opportunities are presented. This overview is not a systematic review but aims to present the current perspective and hence summarizes the most up-to-date research results and reviews. This is the first review providing a summary of the broad spectrum of possibilities to acoustically influence sleep.
Does sound stimulation have additive effects on cognitive-behavioral treatment of chronic tinnitus? [2022]Psychological and physiological habituation are major goals in the treatment of patients suffering from chronic tinnitus. This study evaluates whether sound stimulation provided by use of low level white noise generators (NG) enhances the effects of cognitive-behavioral treatment (CBT). 124 outpatients with tinnitus of >6 months received manualized group treatment and were randomly assigned to the NG/no NG conditions. Those with moderate tinnitus-related distress obtained four sessions focusing on education, while severely distressed subjects were treated according to a full 10-session CBT program. Outcome was assessed at post-treatment and at 6- and 18-month follow-up. No additive effects due to the NGs could be demonstrated. All groups improved significantly on measures of tinnitus-related distress, dysfunctional cognitions, general psychopathology, depression, hypochondriasis and psychosocial functioning. Beneficial effects of the NGs were only observed for patients with concurrent tinnitus and hyperacusis. As systematic physical stimulation of the auditory system does not further improve the effects of CBT, the importance and strength of psychological interventions are emphasized. The clinical relevance of recently developed "retraining" approaches accentuating physical stimulation should be reconsidered.
Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial. [2023]Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression.
Potential Benefits of an Integrated Electric-Acoustic Sound Processor with Children: A Preliminary Report. [2020]A number of published studies have demonstrated the benefits of electric-acoustic stimulation (EAS) over conventional electric stimulation for adults with functional low-frequency acoustic hearing and severe-to-profound high-frequency hearing loss. These benefits potentially include better speech recognition in quiet and in noise, better localization, improvements in sound quality, better music appreciation and aptitude, and better pitch recognition. There is, however, a paucity of published reports describing the potential benefits and limitations of EAS for children with functional low-frequency acoustic hearing and severe-to-profound high-frequency hearing loss.
Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. [2019]To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies.
A Soft Housing Needle Ultrasonic Transducer for Focal Stimulation to Small Animal Brain. [2020]Conventional acoustic brain stimulators that transmit low frequency (
Preliminary study to determine an optimal mode for favorable residual hearing at low frequencies: Full electrical stimulation, electric acoustic stimulation, and electrical complement. [2022]In this prospective study, each subject experienced three modes electric acoustic stimulation (EAS), full electrical stimulation (FES), and electrical complement (EC), and the performance of each mode and subject preference were evaluated.
Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial. [2022]Depressive disorders are the most common form of mental disorders in community and health care settings. Unfortunately, the treatment of Major Depressive Disorder (MDD) is far from satisfactory. Vagus nerve stimulation (VNS) is a relatively new and promising physical treatment for depressive disorders. One particularly appealing element of VNS is the long-term benefit in mood regulation. However, because this intervention involves surgery, perioperative risks, and potentially significant side effects, this treatment has been limited to those patients with treatment-resistant depression who have failed medication trials and exhausted established somatic treatments for major depression, due to intolerance or lack of response.This double-blinded randomized clinical trial aims to overcome these limitations by introducing a novel method of stimulating superficial branches of the vagus nerve on the ear to treat MDD. The rationale is that direct stimulation of the afferent nerve fibers on the ear area with afferent vagus nerve distribution should produce a similar effect as classic VNS in reducing depressive symptoms without the burden of surgical intervention.
Alternating current cranial electrotherapy stimulation (CES) for depression. [2023]Depression is a mood disorder with a prevalence of approximately 1% to 3% worldwide, representing the fourth leading cause of disease burden globally. The current standard treatments of psychological therapy and antidepressant medications are not effective for everyone, and psychotropic drugs may be associated with significant adverse effects. Cranial electrical stimulation (CES) treatment, in which a low intensity electrical current is administered through the use of a small, portable electrical device, has been reported to have efficacy in the treatment of depression with minimal adverse effects. This systematic review investigated the scientific evidence regarding the efficacy and safety of CES in treatment of acute depression compared to sham, or simulated, CES treatment.