Auditory Stimulation for Insomnia and Depression

Official title

Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression

Overview

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

• Device Alpha 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.
• Device Sham 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.

Primary outcome measures

• Sleep Onset Latency - Measurement 1 [Time frame: from baseline to week 2]
• Wake after sleep onset - Measurement 1 [Time frame: from baseline to week 2]
• Sleep Onset Latency - Measurement 2 [Time frame: from baseline to week 4]
• Wake after sleep onset - Measurement 2 [Time frame: from baseline to week 4]

Secondary outcome measures (7)

• Insomnia Severity Index [Time frame: Baseline, Week 2, Week 4]
• Epworth Sleepiness Scale (ESS) [Time frame: Baseline, Week 2, Week 4]
• Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, Week 2, Week 4]
• Beck's Depression Inventory (BDI) [Time frame: Baseline, Week 2, Week 4]
• Satisfaction Survey [Time frame: Week 2, Week 4]
• Subjective Sleep Onset Latency [Time frame: Baseline, Week 2, Week 4]
• Subjective wake after sleep onset [Time frame: Baseline, Week 2, Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Publications

• Bressler S, Neely R, Yost RM, Wang D, Read HL. A wearable EEG system for closed-loop neuromodulation of sleep-related oscillations. J Neural Eng. 2023 Oct 5;20(5). doi: 10.1088/1741-2552/acfb3b. PMID 37726002
• Peterson MJ, Benca RM. Sleep in mood disorders. Psychiatr Clin North Am. 2006 Dec;29(4):1009-32; abstract ix. doi: 10.1016/j.psc.2006.09.003. PMID 17118279
• Bressler S, Neely R, Yost RM, Wang D. Author Correction: A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia. Sci Rep. 2024 Sep 19;14(1):21867. doi: 10.1038/s41598-024-72802-4. No abstract available. PMID 39300282

Identifiers

NCT: NCT07553364 · IRB00145704

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗