Acoustic Resonance vs Cognitive Behavioral Therapy for Insomnia
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.12456Who Is on the Research Team?
Ryan Hurt, MD, PhD
Principal Investigator
Mayo Clinic
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for changes in sleep quality and impairment after treatment
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
Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband.
Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
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)
5.
soundhealth.life
soundhealth.life/blogs/press/acoustic-resonance-therapy-offers-promising-treatment-for-chronic-insomniaAcoustic 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 ...
6.
soundhealth.life
soundhealth.life/blogs/wellness/acoustic-resonance-therapy-a-new-frontier-in-behavioral-sleep-medicineA 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% ( ...
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