Acoustic Resonance Therapy versus Cognitive Behavioral Therapy for Chronic Insomnia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Individualized TCM pattern–based thread-embedding acupuncture plus ear acupressure for chronic insomnia

  This study tests whether a personalized traditional Chinese medicine approach using thread-embedding acupuncture and ear acupressure helps adults with chronic insomnia more than a standard fixed-point protocol.

  Recruiting University of Medicine and Pharmacy at Ho Chi Minh City · Ho Chi Minh City, City · NCT07552714

• A smart look at common sleep meds for insomnia

  This trial tests how well and how safely widely used sleep medicines and OTCs work for adults with insomnia and which might be best overall.

  Recruiting Phase 4 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07542756

• What the Mayo Clinic is learning from blood clot tests in allergic reactions

  This study tests whether real-time blood clotting markers can help understand and predict the severity of allergic reactions and anaphylaxis in patients 12 and older.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07905911

• Atrial Arrhythmia AI-Powered Post-Ablation Predictor Pilot

  This pilot study tests whether AI models using non-invasive heart-mapping data can predict how patients with atrial arrhythmias respond after ablation.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07904377

• A Community Approach to Boost Cervical Cancer Screening for Hispanic and East African Immigrant Women

  The study tests a community-based program that offers self-collection HPV tests and information to Hispanic and East African immigrant women to see if screening rates improve.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07890402

• Point-of-care AI spectroscopy test to triage vulvar lesions

  This pilot study tests whether a handheld AI-powered spectroscopy device can help triage vulvar lesions in adults who are planning surgical removal.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07886203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.