Chronic Insomnia Disorder
Conditions
Keywords
insomnia, cognitive behavioral therapy, acoustic resonance therapy
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).
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
BEHAVIORALMayo 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.
DEVICEAcoustic 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | Baseline, 12 weeks | 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. |
| Sleep Impairment | Baseline, 12 weeks | 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. |
Countries
United States
Contacts
CONTACTStephanie Lindeen, RN
CONTACTShawn C Fokken, CCRP
PRINCIPAL_INVESTIGATORRyan Hurt, MD, PhD
Mayo Clinic
PRINCIPAL_INVESTIGATORIvana T Croghan, PhD
Mayo Clinic
Outcome results
None listed