Auditory Stimulation for Insomnia and Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorWake Forest University Health Sciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to complete overnight EEG study including placement of EEG leads
Ability to read and understand English
Presence of Insomnia
Moderate Depression
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Alpha phase-locked auditory stimulation
DeviceUsing 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.
Sham Stimulation
DeviceUsing 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Alpha phase-locked auditory stimulationExperimental treatment 1 intervention
Group B: Sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Onset Latency - Measurement 1
Change in sleep onset latency (number of minutes) recorded using ENMod
Time frame
from baseline to week 22
Wake after sleep onset - Measurement 1
Change in wake after sleep onset (number of minutes) recorded using ENMod
Time frame
from baseline to week 23
Sleep Onset Latency - Measurement 2
Change in sleep onset latency (number of minutes) recorded using ENMod
Time frame
from baseline to week 44
Wake after sleep onset - Measurement 2
Change in wake after sleep onset (number of minutes) recorded using ENMod
Time frame
from baseline to week 4Secondary outcomes
1
Insomnia Severity Index
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.
Time frame
Baseline, Week 2, Week 42
Epworth Sleepiness Scale (ESS)
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.
Time frame
Baseline, Week 2, Week 43
Patient Health Questionnaire (PHQ-9)
9 items with total score range 0-27. Higher scores indicate greater severity of depressive symptoms.
Time frame
Baseline, Week 2, Week 44
Beck's Depression Inventory (BDI)
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.
Time frame
Baseline, Week 2, Week 4Other outcomes
1
Generalized Anxiety Disorder (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item, self-report questionnaire designed to measure the severity of generalized anxiety, based on symptoms experienced over the last two weeks. Scores range from 0-21, with higher scores indicating increased severity. A score above 10 is generally considered clinical anxiety.
Time frame
Baseline, Week 2, Week 42
Munich Chronotype Questionnaire (MQCT)
The Munich Chronotype Questionnaire (MQCT) is a 19-item self-report questionnaire designed to assess an individual's chronotype, or preference for sleep-wake times. Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotypes.
Time frame
Baseline3
Hamilton Depression Rating Scale (HAMD-17)
Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered tool designed to evaluate the severity of depressive symptoms in adults. It assesses 17 areas, including mood, guilt, suicide, insomnia, and somatic symptoms. The total score range is 0-52, with higher scores indicating more severe depression.
Time frame
Baseline, Week 4Sponsors and contacts
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Source ClinicalTrials.gov
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