Recruiting

CBT-I vs. ART

Sponsor:

Mayo Clinic

Code:

NCT07486882

Conditions

Chronic Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)

Acoustic Resonance Therapy (ART)

Study Details

Brief 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).

Conditions

Chronic Insomnia Disorder

Study ID

NCT07486882

Start date

Mar 17, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 measure

  • Sleep Disturbance [ Time Frame: Baseline, 12 weeks ]
  • Sleep Impairment [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Stephanie Lindeen, RN

507-7293-2740GIMResearchStudies@mayo.edu

Shawn C Fokken, CCRP

507-7293-2740GIMResearchStudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Stephanie Lindeen, RN

507-293-2470GIMResearchStudies@mayo.edu

Shawn C Fokken, CCRP

507-293-2470GIMResearchStudies@mayo.edu

Principal Investigator:

Ryan T Hurt, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • insomnia
  • cognitive behavioral therapy
  • acoustic resonance therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.