Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07486882
Status
Recruiting
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Conditions

  • Chronic Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) — BEHAVIORAL
    The interactive learning module used at Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) focuses on five components: * Sleep hygiene * Stimulus control * Sleep restriction * Worry management * Relaxation training The module includes goal-setting prompts, knowledge tests, and informational videos. Participants will utilize the CCBT-I modules daily for 6 weeks.
  • Acoustic Resonance Therapy (ART) — DEVICE
    The basis behind the SONU Headband system is acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband. Participants will utilize the SONU headband to receive a 45-minute audio session of the personalized binaural beats audio every evening prior to sleep for a duration of 6 weeks.

Study Details

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).

Key Dates

Start date
Mar 17, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A wearable headband (SONU)
    Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband.
  • Active Comparator: Interactive Modules delivering cognitive behavioral therapy for insomnia
    Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules.

Primary Outcome Measure

Sleep Disturbance [ Time Frame: Baseline, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Stephanie Lindeen, RN
[email protected]
507-293-2470
Shawn C Fokken, CCRP
[email protected]
507-293-2470
Ryan T Hurt, MD, PhD (PRINCIPAL_INVESTIGATOR)
Ivana T Croghan, PhD (PRINCIPAL_INVESTIGATOR)

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