Clinical trial NCT05743114: Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
Official title: Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Disturbance
Keywords: Neuromodulation
Electroencephalogram
Auditory Stimulation
Sleep
Wake After Sleep Onset
Lead sponsor: Elemind Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.

Detailed description: In healthy sleepers, cortical alpha oscillations are present during the transition from wakefulness to sleep, and dissipate at sleep onset. For individuals with insomnia, alpha power is elevated during the wake-sleep transition and can persist throughout the night. This study tests whether a wearable device that delivers auditory stimulation phase-locked to alpha oscillations can accelerate sleep onset in healthy adults who report difficulties falling and staying asleep. The device is a prototype of the Elemind Neuromodulation system (ENMod). The ENMod is a wireless headband that measures brain signals, computes the phase of neural oscillations in specific frequency bands, and delivers audible pink noise pulses at specific times relative to the instantaneous phase of neural oscillations. In this study, we ask participants to wear the ENMod headband at home while going to sleep. The device is programmed to record EEG activity and, during the transition from wakefulness to sleep, deliver phase-locked sounds that are intended to interact with the participants neural activity and accelerate sleep onset.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent after reading and answering questions in written English
* Self-report that it takes 30 minutes on average or more to fall asleep
* Subthreshold to Moderately severe Clinical insomnia symptoms (ISI \< 21)
* Subthreshold to Moderately severe Clinical insomnia (PSQI \> 6)
* Minimal risk for severe Generalized Anxiety Disorder (GAD-7 \< 15)
* Minimal risk for severe Generalized Anxiety Disorder (GAD-7 \< 15)
* Individuals that are not actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
* Self-report of difficulty staying asleep "Moderate," "Severe," or "Very Severe"
* Self report of waking up in the middle of the night/early morning one or more times per week

Exclusion Criteria:

* Unable to read or understand English
* Body Mass Index (weight/height ratio) \>33
* Self-report of being diagnosed with apnea
* Current or past history of a neurological disorder or psychiatric illness
* Self-report that it takes less than 30 minutes to fall asleep on average
* Severe Clinical insomnia symptoms (ISI \> 21)
* Good sleepers (PSQI \< 6)
* High risk for severe Generalized Anxiety Disorder (GAD-7 \> 15)
* Moderate to high risk for alcohol abuse disorder (AUDIT \>6)
* individuals that are actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
* Consumption of more than 4 cups of Caffeinated beverages per day
* Any caffeine \< 6hrs prior to each recording session (e.g. coffee, tea, caffeinated sodas etc.)
* Any seizures or family history of seizures
* History of migraine
* History of brain related injury or unexplained loss of consciousness
* Cardiac pacemaker or intracranial metal implant
* Pregnant
* Taking any anti-depressants, stimulants, medication for hypertension or hypotension and/or cannabis derived products
* Cochlear implant in either ear
* Diagnosed with hearing impairment or deafness
* Works night shifts any night of the week

Primary outcomes:
measure: Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
timeFrame: At the completion of the study (14 days), including at least 4 days in each block.
Secondary outcomes:
measure: Change in Sleep Efficiency During Sham Block Compared to Stimulation Block
timeFrame: At the completion of the study (14 days), including at least 4 days in each block.
measure: Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions
timeFrame: At the completion of the study (7-14 days).
measure: Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
timeFrame: At the completion of the study (14 days).
measure: Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
timeFrame: At the completion of the study (14 days).
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Elemind Technologies, Inc
state: Massachusetts
Study officials:
References: