Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time

NCT05743114 | Completed

• 1 other identifier: 2020-02-13
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Disturbance

Keywords

Neuromodulation; Electroencephalogram; Auditory Stimulation; Sleep; Wake After Sleep Onset

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block

  SOL will be determined using objective EEG-based metrics (e.x. time to first observed sleep spindle) derived from recommendations set forth by the American Academy of Sleep Medicine (AASM). SOL will be assessed for each study day during the sham block in which the device is worn but inactive and compared to SOL for the days in the stimulation block, in which the device is actively delivering auditory stimulation. Subjects will randomly be assigned in regards to the order of sham and stimulation blocks.

  At the completion of the study (14 days), including at least 4 days in each block.

Secondary Outcomes (4)

• Change in Sleep Efficiency During Sham Block Compared to Stimulation Block

  At the completion of the study (14 days), including at least 4 days in each block.

• Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions

  At the completion of the study (7-14 days).

• Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block

  At the completion of the study (14 days).

• Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block

  At the completion of the study (14 days).

Study Arms (2)

Sleep Onset Latency Crossover

EXPERIMENTAL

Arm 1 is a crossover arm in which participants receive one block of active stimulation (experimental) and a second block in which the device is worn and actively recording, but not delivering phase-locked auditory stimulation (sham). The order of blocks is randomized for each participant.

Device: Elemind Neuromodulation (ENMod)

Wake After Sleep Onset

EXPERIMENTAL

This arm tests active stimulation during sleep onset, as well as additional stimulation if participants wake up during the night. One of 4 possible conditions are randomized for each stimulation even (within subject and within nights): Stimulation locked to alpha peak phase, stimulation locked to alpha trough phase, white noise (active sham), and no sound (control).

Device: Elemind Neuromodulation (ENMod)

Interventions

Elemind Neuromodulation (ENMod) DEVICE

The ENMod is a headband that measures electroencephalogram (EEG) activity, computes the phase of neural oscillations in real-time, and delivers auditory pulses intended to interact with ongoing neural oscillations.

Sleep Onset Latency Crossover; Wake After Sleep Onset

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elemind Technologies, Inc.: lead

Study Sites (1)

Elemind Technologies, Inc

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

• Bressler S, Neely R, Yost RM, Wang D. A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia. Sci Rep. 2024 Jun 6;14(1):13039. doi: 10.1038/s41598-024-63385-1.

  PMID: 38844793 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Conditions are blinded to the participant and during data analysis and sleep scoring
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 24, 2023
• Study Start: February 2, 2020
• Primary Completion: November 15, 2023
• Study Completion: January 10, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)