NCT07486882

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

March 17, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

March 17, 2026

Last Update Submit

July 16, 2026

Conditions

Chronic Insomnia Disorder

Keywords

insomniacognitive behavioral therapyacoustic resonance therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline, 12 weeks

Study Arms (2)

A wearable headband (SONU)

EXPERIMENTAL

Participants randomized to the SONU Headband arm will receive acoustic resonance therapy (ART) which is delivered through two bone conduction transducers in the headband.

Device: Acoustic Resonance Therapy (ART)

Interactive Modules delivering cognitive behavioral therapy for insomnia

ACTIVE COMPARATOR

Participants randomized to the CBT-I arm will receive Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) learning modules.

Behavioral: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)

Interventions

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.

Also known as: SONU Headband
A wearable headband (SONU)
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.

Interactive Modules delivering cognitive behavioral therapy for insomnia

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Ryan Hurt, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Ivana T Croghan, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Lindeen, RN

CONTACT

507-7293-2740GIMResearchStudies@mayo.edu

Shawn C Fokken, CCRP

CONTACT

507-7293-2740GIMResearchStudies@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial where subjects are placed into 2 different study arms. Subjects are randomized to 2 groups that either receive acoustic resonance therapy through a wearable device or use cognitive behavioral therapy for insomnia accessed through a learning module.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 17, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)