Could a headband that plays sounds beat insomnia?
NCT ID NCT07486882
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This study tests whether a headband that uses sound waves (acoustic resonance therapy) can improve sleep quality in people with moderate to severe chronic insomnia. It compares the headband to a standard behavioral therapy (CBT-I) over 6 weeks. About 60 adults will participate to see which approach works better for sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acoustic Resonance Therapy (SONU headband) and Cognitive Behavioral Therapy for Insomnia (CBT-I)
- What this could lead to
- If successful, this could offer a new, non-drug option for improving sleep quality in people with chronic insomnia.
- What could go wrong
- This is a small, early feasibility pilot with only 60 participants, so results may not apply broadly. The device may not work as well as standard therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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