Depression - Major Depressive Disorder, Insomnia
Conditions
Keywords
sleep, Depression, Insomnia
Brief summary
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
Detailed description
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.
Interventions
DEVICEAlpha phase-locked auditory stimulation
Using the ENMod device, participants will receive alpha phase-locked auditory stimulation delivered as pink noise pulses through a bone conduction driver placed near the middle of the forehead. To mask the sound of the stimulation, natural rain sounds will be played alongside the pink noise.
DEVICESham Stimulation
Using the ENMod device, participants will receive sham stimulation, which is presented as natural rain sounds alone, through a bone conduction driver placed near the middle of the forehead.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency - Measurement 1 | from baseline to week 2 | Change in sleep onset latency (number of minutes) recorded using ENMod |
| Wake after sleep onset - Measurement 1 | from baseline to week 2 | Change in wake after sleep onset (number of minutes) recorded using ENMod |
| Sleep Onset Latency - Measurement 2 | from baseline to week 4 | Change in sleep onset latency (number of minutes) recorded using ENMod |
| Wake after sleep onset - Measurement 2 | from baseline to week 4 | Change in wake after sleep onset (number of minutes) recorded using ENMod |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline, Week 2, Week 4 | The Insomnia Severity Index (ISI) is a 7-item, self-report questionnaire used to assess the severity, nature, and impact of insomnia over the past two weeks. It measures sleep onset, maintenance, early morning awakening, satisfaction, interference with daily functioning, noticeability to others, and distress. Each item is rated on a 0-4 scale, yielding a total score from 0 to 28 where higher scores indicate more severe insomnia. Generally, a score of 15 or more indicates clinical insomnia. |
| Epworth Sleepiness Scale (ESS) | Baseline, Week 2, Week 4 | The Epworth Sleepiness Scale (ESS) is an 8-item self-administered questionnaire to assess an individual's level of daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. A score of 10 or higher generally suggests excessive daytime sleepiness, possibly indicating a sleep disorder. |
| Patient Health Questionnaire (PHQ-9) | Baseline, Week 2, Week 4 | 9 items with total score range 0-27. Higher scores indicate greater severity of depressive symptoms. |
| Beck's Depression Inventory (BDI) | Baseline, Week 2, Week 4 | The Beck Depression Inventory (BDI) is a 21-item, self-report questionnaire used to measure the severity of depression. It focuses on symptoms like sadness, guilt, and fatigue, with each item rated on a 0-3 scale. Scores range from 0-62, with higher scores indicating more severe depression. Generally, a score of 20 or higher indicates clinical depression. |
| Satisfaction Survey | Week 2, Week 4 | This satisfaction survey is an 11-item self-report questionnaire focusing on ease of device use, impact on sleep, likelihood to continue use, and general satisfaction. Scores for each question range from 1-5, and a cumulative average satisfaction score will be calculated for each participant based on their answers. |
| Subjective Sleep Onset Latency | Baseline, Week 2, Week 4 | Sleep onset latency (number of minutes) from baseline to the end of each arm as reported in participant sleep diaries. |
| Subjective wake after sleep onset | Baseline, Week 2, Week 4 | Wake after sleep onset (number of minutes) from baseline to the end of each arm as reported in participant sleep diaries. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRuth Benca, MD, PhD
Wake Forest University Health Sciences
Outcome results
None listed