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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep Impairment
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Acoustic Resonance Therapy (ART) (Device)
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.
干预措施: Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
结局指标
主要结局
Sleep Impairment
时间窗: 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.
Sleep Disturbance
时间窗: 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.
次要结局
未报告次要终点
研究者
Ryan T. Hurt, M.D., Ph.D.
Principal Investigator
Mayo Clinic