Inclusion Criteria:

• Adult subjects, 18 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 which 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: 

• Patients who are unable to commit to avoid 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/07/2024. Questions regarding updates should be directed to the study team contact.