Chronic Insomnia DisorderNCT07486882
Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
A study testing Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acoustic Resonance Therapy (ART) in people with Chronic Insomnia Disorder, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Insomnia Disorder
- What is being tested?
- Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acoustic Resonance Therapy (ART)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Stephanie Lindeen, RN, 507-293-2470, GIMResearchStudies@mayo.edu
Shawn C Fokken, CCRP, 507-293-2470, GIMResearchStudies@mayo.edu
About this study
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
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).
Read the detailed description
This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).
- Conditions
- Chronic Insomnia Disorder
- Being tested
- Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I), Acoustic Resonance Therapy (ART)
- Keywords
- insomnia, cognitive behavioral therapy, acoustic resonance therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
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)Device
Also called SONU Headband
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.
| Study group | Role | What they receive |
|---|---|---|
| A wearable headband (SONU) | Experimental | Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband. Receives: Device: Acoustic Resonance Therapy (ART) |
| Interactive Modules delivering cognitive behavioral therapy for insomnia | Active comparator | Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules. Receives: Behavioral: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance
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.
Measured: Baseline, 12 weeks
Sleep Impairment
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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start17 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial where subjects are placed into 2 different study arms. Subjects are randomized to 2 groups that either receive acoustic resonance therapy through a wearable device or use cognitive behavioral therapy for insomnia accessed through a learning module.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ryan Hurt, MD, PhD, Principal investigator, Mayo ClinicIvana T Croghan, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486882
- Sponsor's protocol ID
- 24-008043
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07486882
- Acronym / sponsor ID
- 24-008043
- Conditions
- Chronic Insomnia Disorder
- Keywords
- insomnia, cognitive behavioral therapy, acoustic resonance therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial where subjects are placed into 2 different study arms. Subjects are randomized to 2 groups that either receive acoustic resonance therapy through a wearable device or use cognitive behavioral therapy for insomnia accessed through a learning module.
| Arm | Type | Receives |
|---|---|---|
| A wearable headband (SONU) | Experimental | Device: Acoustic Resonance Therapy (ART)Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband. |
| Interactive Modules delivering cognitive behavioral therapy for insomnia | Active comparator | Behavioral: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Interactive Modules delivering cognitive behavioral therapy for insomnia |
| Acoustic Resonance Therapy (ART)Also: SONU HeadbandThe 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. | Device | A wearable headband (SONU) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Hurt, MD, PhD principal investigator
Mayo Clinic
Ivana T Croghan, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acoustic Resonance Therapy (ART) in people with Chronic Insomnia Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Lindeen, RN (507-7293-2740, GIMResearchStudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbance (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.