Overview
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
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.
