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Auditory Stimulation for Insomnia

CC
RB
Overseen ByRuth Benca, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Alpha phase-locked auditory stimulation, a special type of sound therapy, can improve sleep in individuals with insomnia and depression. Participants will wear a headband that delivers sound stimulation to determine if it helps them fall asleep faster and stay asleep longer compared to a placebo. Those with sleep difficulties and moderate depression may be suitable candidates, particularly if they can use a smartphone and have internet access. Participants will also wear a watch to track their sleep and complete questionnaires about their sleep and mood. As an unphased trial, this study offers the chance to contribute to innovative research that could enhance sleep and mood for many.

Will I have to stop taking my current medications?

The trial requires that participants not take medications that could alter EEG readings.

What prior data suggests that this auditory stimulation is safe for individuals with insomnia and depression?

Research has shown that using sound in sync with brain waves is generally safe. Studies have found it to be an effective way to help people fall asleep faster without medication. Participants in these studies did not report any major side effects, confirming the method's safety. This technique, tested in adults with insomnia, uses sound to promote quicker sleep onset without major safety concerns. It offers a promising alternative for those seeking to improve sleep without drugs.12345

Why are researchers excited about this trial?

Unlike the standard treatments for insomnia, which typically include medications like benzodiazepines or cognitive behavioral therapy, alpha phase-locked auditory stimulation is unique because it uses sound waves to directly influence brain activity. This technique is non-invasive and aims to synchronize the brain's alpha waves, which are associated with relaxation and sleep. Researchers are excited about this approach because it offers a potential new way to improve sleep quality without the side effects commonly associated with medication. Additionally, it may provide benefits for those who also experience depression, offering a dual-action approach to treatment.

What evidence suggests that alpha phase-locked auditory stimulation is effective for insomnia?

Research has shown that using sound to help people fall asleep faster can be as effective as sleep medications. In this trial, participants may receive Alpha phase-locked auditory stimulation, which plays sounds in sync with brain activity to significantly reduce the time it takes for adults with insomnia to fall asleep. This technology, resembling a headband, matches sounds with brain waves to facilitate sleep. These findings suggest a promising alternative for those who struggle to fall asleep. Another group in this trial will receive Sham Stimulation, serving as a comparator to evaluate the effectiveness of the auditory stimulation.12346

Who Is on the Research Team?

RB

Ruth Benca, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults who have both insomnia and moderate depression, can read and understand English, are able to use a headband device overnight, and have access to a smartphone and home internet.

Inclusion Criteria

I am able to complete an overnight EEG test with leads attached to my head.
* Ability to read and understand English
I have trouble sleeping or insomnia.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants wear the Elemind Neuromod headband and actigraphy watch to establish baseline sleep data

1 week
No in-person visits, remote monitoring

Treatment

Participants undergo either active or sham auditory stimulation using the Elemind Neuromod headband

1 week
No in-person visits, remote monitoring

Washout

Participants do not receive any stimulation to allow for washout effects

1 week
No in-person visits, remote monitoring

Crossover Treatment

Participants switch to the opposite condition (active or sham stimulation) using the Elemind Neuromod headband

1 week
No in-person visits, remote monitoring

Follow-up

Participants complete questionnaires regarding their sleep, mood, and satisfaction with the device

1 week
Remote completion of questionnaires

What Are the Treatments Tested in This Trial?

Interventions

  • Alpha phase-locked auditory stimulation
  • Sham Stimulation

Trial Overview

The study compares two types of nightly sound stimulation using a wearable headband: one with active alpha phase-locked auditory stimulation and one sham (inactive) version. Each participant tries both over several weeks while their sleep is monitored.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Alpha phase-locked auditory stimulationExperimental Treatment1 Intervention
Group II: Sham stimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

A randomized controlled trial of alpha phase-locked ...

These data suggest that phase-locked acoustic stimulation can be a viable alternative to pharmaceuticals to accelerate sleep onset.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38844793/

A randomized controlled trial of alpha phase-locked ...

These data suggest that phase-locked acoustic stimulation can be a viable alternative to pharmaceuticals to accelerate sleep onset.

NCT05743114 | Sounds Locked to ElectroEncephalogram ...

This study tests whether a wearable device that delivers auditory stimulation phase-locked to alpha oscillations can accelerate sleep onset in healthy adults ...

(PDF) A randomized controlled trial of alpha phase-locked ...

These data suggest that phase-locked acoustic stimulation can be a viable alternative to pharmaceuticals to accelerate sleep onset in individuals with prolonged ...

A randomized controlled trial of alpha phase-locked ...

These data suggest that phase-locked acoustic stimulation can be a viable alternative to pharmaceuticals to accelerate sleep onset in ...

A randomized controlled trial of alpha phase-locked auditory ...

The weekly standard deviation in sleep onset times was reduced by 9.60 ± 13.9 min during the week that participants received active stimulation compared to sham ...