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
Qualifiers
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
Treatments tested in this trial
- Alpha phase-locked auditory stimulation
- Sham Stimulation
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov