Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
ConditionChronic Insomnia Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMayo Clinic
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Acoustic Resonance Therapy (ART)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov