NCT07486882 Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
| NCT ID | NCT07486882 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Chronic Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03-17 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Ryan Hurt, MD, PhD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07486882 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Chronic Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07486882 currently recruiting?
Yes, NCT07486882 is actively recruiting participants. Contact the research team at GIMResearchStudies@mayo.edu for enrollment information.
Where is the NCT07486882 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07486882 clinical trial?
NCT07486882 is sponsored by Mayo Clinic. The principal investigator is Ryan Hurt, MD, PhD at Mayo Clinic. The trial plans to enroll 60 participants.
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