Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
Purpose
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).
Condition
- Chronic Insomnia Disorder
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
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).