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Compares treatment options for Chronic Insomnia Disorder
Official title Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
ClinicalTrials.gov ID: NCT07486882
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Adult people, 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...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- Adult people, 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.