NCT07486882 · Mayo Clinic
Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this study is about
The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomly assigned to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment group$1 versus those randomly assigned to the SONU Headband Acoustic Resonance Therapy (ART) treatment group$1 at end of treatment (6 weeks).
View original scientific description
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).
Interventions
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.
Primary outcome measures
Sleep Disturbance
Time frame: Baseline, 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 Impairment
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations