Actively Recruiting
Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
Led by Mayo Clinic · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 22 years of age or older at screening
- Diagnosed with moderate to severe insomnia disorder lasting more than three months
- Not pregnant at time of consent
- Able to provide informed consent
- Able to complete all parts of the trial
- Have access to an iOS mobile device (iPhone X or above)
- No health conditions that would interfere with using the SONU Headband, as determined by the study doctor
- If using sleep-aiding pills, agree not to change medication or dosage during the study
You will not qualify if you...
- Unable to avoid alcohol consumption during the study
- Unable to avoid caffeine after 12 pm (noon)
- Have clinically significant or unstable medical or surgical conditions
- Use pacemakers or cardiac monitors
- Have severe physical illness or are immediately post-surgery
- Have severe mental disorders such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases like seizure, stroke, or Parkinson's disease
- Have other serious sleep disorders such as severe obstructive sleep apnea
- Unable to attend regular follow-up evaluations
- Have any unstable medical or mental health condition as determined by the study doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Stephanie Lindeen, RN
CONTACT
S
Shawn C Fokken, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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