Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Sleep Onset Latency - Measurement 1
研究概览
简要总结
The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following:
Determine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.
The study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation.
Participants will:
- Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active/sham stimulation, 1 week washout, and 1 week opposite condition - active/sham stimulation)
- Wear actigraphy watch for duration of the study
- Complete questionnaires regarding their sleep, mood, and satisfaction with the device
详细描述
The purpose of this pilot study is to determine if non-invasive alpha-phase locked auditory stimulation delivered before sleep can improve objective and subjective sleep outcomes in individuals with depression and insomnia. Moreover, the study team will determine if this protocol design is feasible and acceptable to this population to inform the design of a larger scale clinical trial in this population.
Insomnia is highly prevalent among individuals with major depressive disorder (MDD) and is a strong risk factor for onset and recurrence. Effective treatment of insomnia has been shown to accelerate antidepressant response and reduce suicidal ideation. Insomnia is associated with increased cortical arousal during sleep, reflected by elevated alpha, beta, and theta EEG activity. Although cognitive behavioral therapy for insomnia (CBT-I) and pharmacologic treatments can improve sleep and depression, CBT-I is time-intensive and often inaccessible, while medications pose risks of side effects, dependence, and patient reluctance. Scalable, home-based neuromodulation during sleep represents a promising alternative.
Elemind has developed a closed-loop, audio-driven neurostimulation device that reduces sleep latency by modulating alpha oscillations during pre-sleep quiet wakefulness. The device uses a wearable headband to track sleep stages and deliver precisely timed auditory stimulation to reduce alpha activity and facilitate sleep onset. The auditory stimulation can be applied both at the beginning of the night, and following nighttime awakenings to help reduce sleep onset latency and wake after sleep onset.
After screening and enrolling in the study, participants will wear the headband to sleep nightly for up to 4 weeks, including one week of baseline, one week of either active or sham stimulation, 1 week of washout, and 1 final week of the opposite stimulation condition. Participants will also wear an actigraphy watch and keep a sleep diary throughout the duration of the study. Finally, participants will complete several questionnaires regarding their sleep, mood, and satisfaction with the device throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to complete overnight EEG study including placement of EEG leads
- •Ability to read and understand English
- •Presence of Insomnia
- •Moderate Depression
- •Home internet and smartphone (Android or Apple) device access
排除标准
- •Presence of severe, untreated sleep apnea
- •Presence of restless leg syndrome
- •Significant neurological disease (e.g. Parkinson's disease, epilepsy)
- •Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation
- •Has active implanted device ( e.g. intracranial device, cochlear implant)
- •Currently deaf or experiencing hearing loss or using hearing aids
- •Currently taking medications that could alter EEG
- •Currently pregnant
研究组 & 干预措施
Alpha phase-locked auditory stimulation
participants with symptoms of insomnia and depression
干预措施: Alpha phase-locked auditory stimulation (Device)
Sham stimulation
participants with symptoms of insomnia and depression
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Sleep Onset Latency - Measurement 1
时间窗: from baseline to week 2
Change in sleep onset latency (number of minutes) recorded using ENMod
Wake after sleep onset - Measurement 1
时间窗: from baseline to week 2
Change in wake after sleep onset (number of minutes) recorded using ENMod
Sleep Onset Latency - Measurement 2
时间窗: from baseline to week 4
Change in sleep onset latency (number of minutes) recorded using ENMod
Wake after sleep onset - Measurement 2
时间窗: from baseline to week 4
Change in wake after sleep onset (number of minutes) recorded using ENMod
次要结局
- Satisfaction Survey(Week 2, Week 4)
- Insomnia Severity Index(Baseline, Week 2, Week 4)
- Epworth Sleepiness Scale (ESS)(Baseline, Week 2, Week 4)
- Patient Health Questionnaire (PHQ-9)(Baseline, Week 2, Week 4)
- Beck's Depression Inventory (BDI)(Baseline, Week 2, Week 4)
- Subjective Sleep Onset Latency(Baseline, Week 2, Week 4)
- Subjective wake after sleep onset(Baseline, Week 2, Week 4)