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Comparing a sound headband with talk-based therapy for long-term insomnia

Compares a sound headband with behavioral therapy for sleep in adults with chronic insomnia.

Key facts

Who runs it
Mayo Clinic
Where
Rochester, United StatesSee the site
Trial code
Registry title
Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
Status
Recruiting
People taking part
60 people, planned
Started
17 Mar 2026
Expected to end
31 Jul 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Acoustic Resonance Therapy (ART)
Record updated
20 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe chronic insomnia. It compares a sound-therapy headband (SONU) with online CBT-I lessons over 6 weeks.

Age
22 years and older
Sex
All sexes
Disease stage
Moderate to severe insomnia disorder by ICSD-3 and the Insomnia Severity Index (ISI), diagnosed more than three months ago.
Earlier treatment
People taking sleep pills can join if they keep the same medicine and dose during the study.

Main reasons for not taking part

  • Pregnancy (by your own report at consent)
  • Using a pacemaker or heart monitor
  • Severe mental illness or severe nerve disease, such as schizophrenia, bipolar disorder, dementia, seizures, stroke or Parkinson's disease
  • Other serious sleep disorders, such as severe obstructive sleep apnea
  • Unable to avoid alcohol, or caffeine after 12 pm (noon), during the study

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Any unstable medical or mental health condition as determined by the physician investigator
  • 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)
  • Participants who are unable to attend regular follow-up evaluations

Where in United States

  • Mayo Clinic in RochesterRochester, United StatesContact: Stephanie Lindeen, RNTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • A wearable headband (SONU)Treatment being tested

    Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband.

    Treatment: Acoustic Resonance Therapy (ART)

  • Interactive Modules delivering cognitive behavioral therapy for insomniaExisting treatment, for comparison

    Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Comparing a sound headband with talk-based therapy for long-term insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
20 July 2026