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Recruiting NCT07486882

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

No phase Interventional Chronic Insomnia Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I), Acoustic Resonance Therapy (ART).
Who it may be relevant to
Registry conditions: Chronic Insomnia Disorder. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder

Overview

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).

Detailed description

This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).

Interventions

  • Behavioral Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)
    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.
  • Device Acoustic Resonance Therapy (ART)
    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.

Primary outcome measures

  • Sleep Disturbance [Time frame: Baseline, 12 weeks]
  • Sleep Impairment [Time frame: Baseline, 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • 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, 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07486882 · 24-008043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗