60 Participants NeededMy employer runs this trial

Acoustic Resonance vs Cognitive Behavioral Therapy for Insomnia

SL
SC
Overseen ByShawn C Fokken, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Sleep-aiding pills
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 aims to compare two treatments for improving sleep quality in people with moderate to severe insomnia. Participants will either use a SONU Headband that provides Acoustic Resonance Therapy (ART) or engage in Cognitive Behavioral Therapy for Insomnia (CBT-I) through interactive modules. Ideal candidates are adults who have experienced insomnia for more than three months and can use an iPhone X or newer.

As an unphased trial, this study allows participants to explore innovative treatments for insomnia and contribute to advancing sleep research.

Do I have to stop taking my current medications for the trial?

If you are taking sleep-aiding pills, you must not change your medication or dosage during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found Acoustic Resonance Therapy (ART) to be safe and effective for treating insomnia. Participants using ART reported significantly improved sleep quality. The absence of major side effects makes it a well-tolerated option for enhancing sleep. Research on the Mayo Clinic's Cognitive Behavioral Therapy for Insomnia (CBT-I) has shown it to be very safe, with few or no side effects. CBT-I often matches the effectiveness of sleep medications but lacks the usual side effects. Both treatments are considered safe options for managing insomnia.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for insomnia because they offer innovative approaches compared to traditional methods like medication or standard cognitive behavioral therapy. Acoustic Resonance Therapy (ART) is unique as it uses a wearable headband with bone conduction transducers to deliver therapeutic sound frequencies, which could provide a non-invasive and drug-free alternative. In contrast, the Mayo Clinic's CBT-I uses interactive modules for personalized cognitive behavioral strategies, enhancing accessibility and convenience for users. Together, these treatments have the potential to offer more personalized and less invasive solutions for those struggling with insomnia.

What evidence suggests that this trial's treatments could be effective for insomnia?

This trial will compare Acoustic Resonance Therapy (ART) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Research has shown that ART, which participants in the SONU Headband arm will receive, can significantly improve insomnia symptoms. One study found that nearly 45% of participants reduced their Insomnia Severity Index (ISI) scores below 7 after four weeks, indicating much better sleep. Other studies have also found that ART generally reduces insomnia severity based on standard sleep quality scores.

Participants in the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia. CBT-I is a well-known treatment that matches the effectiveness of sleep medications without the side effects. It typically reduces insomnia severity, often improving sleep quality and helping individuals fall asleep faster. Some studies have shown that the benefits can last a long time, with many people experiencing better sleep for years after treatment.12456

Who Is on the Research Team?

RH

Ryan Hurt, MD, PhD

Principal Investigator

Mayo Clinic

IT

Ivana T Croghan, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 22 and older who have had moderate to severe insomnia for over three months. Participants must not be pregnant, need to use an iPhone X or newer, and should not have health issues that prevent using the SONU Headband. They must agree not to change any sleep medications during the study.

Inclusion Criteria

* Not pregnant by subject self-report at time of consent.
* Have the ability to provide informed consent.
I am able to follow all trial instructions and attend required visits.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either Acoustic Resonance Therapy (ART) using a wearable headband or Cognitive Behavioral Therapy for Insomnia (CBT-I) through interactive modules for 6 weeks

6 weeks

Follow-up

Participants are monitored for changes in sleep quality and impairment after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acoustic Resonance Therapy (ART)
  • Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)

Trial Overview

The study compares two treatments for insomnia: Cognitive Behavioral Therapy (CBT-I) and Acoustic Resonance Therapy (ART) delivered via a headband device. Participants are randomly assigned to one of these groups for six weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: A wearable headband (SONU)Experimental Treatment1 Intervention
Group II: Interactive Modules delivering cognitive behavioral therapy for insomniaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

A systematic review and meta-analysis of acoustic stimulation ...

The results showed that acoustic stimulation significantly improved insomnia severity as evidenced by PSQI and ISI scores. Despite no ...

Comparing Acoustic Resonance Therapy (ART) vs. ...

The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to ...

Use of Customized Binaural Beats for the Treatment of ...

This single-center interventional study evaluated the safety and efficacy of the spatial acoustic resonance therapy (ART) device (SoundHealth ...

Clinical Trials

The purpose of this study is to compare changes in sleep quality (as measured by the PROMIS-Disturbance Scale and the PROMIS Impairment Scale)

Acoustic resonance therapy offers promising treatment for ...

After four weeks of treatment, nearly half of the participants (45%) achieved an Insomnia Severity Index (ISI) score below 7, indicating a ...

A New Frontier in Behavioral Sleep Medicin

Major improvement in sleep: The average ISI score of the participants dropped from 19.8 to 8.5 after four weeks of using the device. · High response rate: 75% ( ...