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
Mayo Clinic
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).
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).
Eligibility
- Age range
- 22+ years
- Sex
- All
- 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 us…
Interventions
- BehavioralMayo 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.
- DeviceAcoustic Resonance Therapy (ART)
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.
Location
- Mayo Clinic in RochesterRochester, Minnesota