NCT07486882

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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).

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).

Conditions

• Chronic Insomnia Disorder

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-03-31
• Completion: 2027-07-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study