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

This study is comparing two ways to help people with chronic insomnia disorder: Acoustic Resonance Therapy (ART) using the SONU Headband, and Cognitive Behavioral Therapy for Insomnia (CBT-I) from Mayo Clinic. You might be able to join if you are an adult, 22 years or older, with moderate to severe insomnia that has lasted for more than three months. The study aims to see which treatment better improves sleep disturbance and sleep impairment after 12 weeks. The current recruitment status is unclear.

Study design: This study will randomly assign 60 participants to one of two treatments for 6 weeks: either the SONU Headband (ART) or the Mayo Clinic CBT-I learning module.
What's involved: Participants will use the SONU headband for a 45-minute audio session every evening, or engage with an interactive learning module for CBT-I. The treatment period is 6 weeks.
Compensation: Not stated in the trial record.
Follow-up: Sleep disturbance and sleep impairment will be measured at baseline and again at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 22+InterventionalTreatment

Mayo Clinic

~60 participants

Updated 2026-07-20 on ClinicalTrials.gov

What's tested:Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)Acoustic Resonance Therapy (ART)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Sleep Disturbance

Measured over Baseline, 12 weeks

+1 more outcome measured

Conditions

Chronic Insomnia Disorder

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Ryan Hurt, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Ivana T Croghan, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Stephanie Lindeen, RN

[email protected]

507-7293-2740

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Sleep DisturbanceBaseline, 12 weeks
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep where a high score indicates self-reported perceptions of difficulties or concerns with sleep.
Sleep ImpairmentBaseline, 12 weeks
The Patient-Reported Outcomes Measurement Information System Sleep Impairment 8a instrument assesses self-reported perceptions of sleep related issues in patients where a high score indicates self-reported patient perceptions of experience in sleep impairment.

Trialytics