Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)

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

The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) arm versus those randomized to the SONU Headband Acoustic Resonance Therapy (ART) arm at end of treatment (6 weeks).

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia Disorder
• Intervention / Treatment: Device: Acoustic Resonance Therapy (ART); Behavioral: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)

Detailed Description

This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Lindeen, RN; Phone Number: 507-7293-2740; Email: GIMResearchStudies@mayo.edu
• Study Contact Backup: Name: Shawn C Fokken, CCRP; Phone Number: 507-7293-2740; Email: GIMResearchStudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Ivana T Croghan, PhD
      • Principal Investigator: Ryan T Hurt, MD, PhD
      • Contact: Stephanie Lindeen, RN; Phone Number: 507-293-2470; Email: GIMResearchStudies@mayo.edu
      • Contact: Shawn C Fokken, CCRP; Phone Number: 507-293-2470; Email: GIMResearchStudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A wearable headband (SONU); Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband.	Device: Acoustic Resonance Therapy (ART); The basis behind the SONU Headband system is acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband. Participants will utilize the SONU headband to receive a 45-minute audio session of the personalized binaural beats audio every evening prior to sleep for a duration of 6 weeks.; Other Names: SONU Headband
Active Comparator: Interactive Modules delivering cognitive behavioral therapy for insomnia; Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules.	Behavioral: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I); The interactive learning module used at Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) focuses on five components: Sleep hygiene; Stimulus control; Sleep restriction; Worry management; Relaxation training The module includes goal-setting prompts, knowledge tests, and informational videos. Participants will utilize the CCBT-I modules daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance	The PROMIS Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.	Baseline, 12 weeks
Sleep Impairment	The PROMIS Sleep Impairment 8a instrument assesses self-reported perceptions of sleep related issues in patients.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic; Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; cognitive behavioral therapy; acoustic resonance therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 24-008043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No