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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: A wearable headband (SONU)Experimental treatment 1 intervention

Group B: Interactive Modules delivering cognitive behavioral therapy for insomniaActive comparator 1 intervention

Trial outcomes

Primary outcomes

Sleep Disturbance

The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep where a high score indicates self-reported perceptions of difficulties or concerns with sleep.

Time frame

Baseline, 12 weeks

Sleep Impairment

The Patient-Reported Outcomes Measurement Information System Sleep Impairment 8a instrument assesses self-reported perceptions of sleep related issues in patients where a high score indicates self-reported patient perceptions of experience in sleep impairment.

Time frame

Baseline, 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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