Acoustic Resonance Therapy versus Cognitive Behavioral Therapy for Chronic Insomnia.
A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder
This will test whether a SONU headband using Acoustic Resonance Therapy or an interactive CBT-I program helps adults with moderate-to-severe chronic insomnia sleep better after six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07486882 on ClinicalTrials.gov |
What this trial studies
This randomized, single-site study will enroll 60 adults with moderate-to-severe chronic insomnia and assign them to one of two six-week interventions: a wearable SONU Headband delivering Acoustic Resonance Therapy (ART) or an interactive cognitive behavioral therapy for insomnia (CBT-I) program. Sleep quality and related measures will be collected at baseline and at the end of treatment to compare changes between the two groups. Participants must have an iPhone X or newer and be able to complete all study procedures at Mayo Clinic in Rochester, Minnesota. Medication regimens must remain stable during the study to reduce confounding.
Who should consider this trial
Good fit: Adults aged 22 years or older with moderate-to-severe chronic insomnia who can provide informed consent, have an iPhone X or newer, and can complete study procedures are ideal candidates.
Not a fit: Those who are pregnant, lack a compatible iOS device, have comorbid conditions that contraindicate use of the SONU Headband, or cannot keep sleep medications unchanged during the study may not receive benefit from participation.
Why it matters
Potential benefit: If successful, ART could provide an effective, non-drug, at-home alternative to CBT-I for adults with chronic insomnia.
How similar studies have performed: Cognitive Behavioral Therapy for Insomnia (CBT-I) has strong, well-established evidence of benefit, while Acoustic Resonance Therapy delivered by headband is a newer approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects, 22 years of age and older at screening * Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)\* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months. * Not pregnant by subject self-report at time of consent. * Have the ability to provide informed consent. * Have the ability to complete all aspects of this trial. * Have access to an iOS mobile device (iPhone X or above). * Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators. * Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study. * According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality Exclusion Criteria: * Patients who are unable to commit to avoiding the consumption of alcohol during the study. * Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon). * Patients who have a clinically significant or unstable medical or surgical condition. * Participants using pacemakers or cardiac monitors. * Participants with severe physical illness or immediately post-surgery * Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease. * Participants with other serious sleep disorders, such as severe obstructive sleep apnea. * Participants who are unable to attend regular follow-up evaluations. * Any unstable medical or mental health condition as determined by the physician investigator.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Hurt, MD, PhD — Mayo Clinic
- Study coordinator: Stephanie Lindeen, RN
- Email: GIMResearchStudies@mayo.edu
- Phone: 507-7293-2740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.