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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | The interactive learning module used at Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) focuses on five components:
The module includes goal-setting prompts, knowledge tests, and informational videos. Participants will utilize the CCBT-I modules daily for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance | The PROMIS Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. | Baseline, 12 weeks |
| Sleep Impairment | The PROMIS Sleep Impairment 8a instrument assesses self-reported perceptions of sleep related issues in patients. | Baseline, 12 weeks |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Lindeen, RN | Contact | 507-7293-2740 | GIMResearchStudies@mayo.edu | |
| Shawn C Fokken, CCRP | Contact | 507-7293-2740 | GIMResearchStudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Hurt, MD, PhD | Mayo Clinic | Principal Investigator |
| Ivana T Croghan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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.
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| Acoustic Resonance Therapy (ART) | Device | 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. |
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| D001523 |
| Mental Disorders |