Auditory Stimulation for Insomnia and Depression

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.