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

Primary Purpose

Sleep, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elemind Neuromodulation (ENMod)
Sponsored by
Elemind Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring Neuromodulation, Electroencephalogram, Auditory Stimulation, Sleep, Wake After Sleep Onset

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Elemind Technologies, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep Onset Latency Crossover

Wake After Sleep Onset

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Sleep Efficiency During Sham Block Compared to Stimulation Block
Sleep efficiency, defined as the percentage of time spent asleep out of the total time spent in bed will assessed for each study day during the sham block in which the device is worn but inactive and compared to the sleep efficiency for each day 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.
Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions
Sleep onset latency will be measured after middle-of-night wake up events using EEG-based metrics according to guidelines set forth by the American Academy of Sleep Medicine (AASM). Stimulation condition (sham or active) will be randomized for each WASO event (including events within a single night as well as across all nights). At the completion of the study, SOL will be compared for WASO events in which sham stimulation was delivered compared to WASO events in which active stimulation was delivered.
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Subject-reported time to fall asleep will be assessed using the results from a questionnaire that includes the first 9 questions from the Consensus Sleep Diary (Carney et al., 2012). This survey asks the participant to report bed time, wake time, the amount of time it took to fall asleep, the number of awakenings during the night and the total duration of such awakenings. The questionnaire also asks the subject to rate quality of sleep on a 5-point scale from very poor to very good. The reported time to fall asleep on days during the sham block will be compared to the same metric reported on days during the stimulation block.
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
Subject-reported feelings of sleepiness and alertness during the day will be assessed using the Karolinska Sleepiness Scale (KSS) questionnaire. This is a single question scale on which sleepiness is assessed using a score from 1-9, with 1 representing a level of high alertness, and 9 representing very sleepy. The reported KSS score during the sham block will be compared to the same metric reported on days during the stimulation block.

Full Information

First Posted
February 6, 2023
Last Updated
February 14, 2023
Sponsor
Elemind Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05743114
Brief Title
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
Acronym
SLEEPFAST
Official Title
Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2020 (Actual)
Primary Completion Date
November 11, 2024 (Anticipated)
Study Completion Date
November 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elemind Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Disturbance
Keywords
Neuromodulation, Electroencephalogram, Auditory Stimulation, Sleep, Wake After Sleep Onset

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Conditions are blinded to the participant and during data analysis and sleep scoring
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Onset Latency Crossover
Arm Type
Experimental
Arm Description
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.
Arm Title
Wake After Sleep Onset
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Elemind Neuromodulation (ENMod)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Description
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.
Time Frame
At the completion of the study (14 days), including at least 4 days in each block.
Secondary Outcome Measure Information:
Title
Change in Sleep Efficiency During Sham Block Compared to Stimulation Block
Description
Sleep efficiency, defined as the percentage of time spent asleep out of the total time spent in bed will assessed for each study day during the sham block in which the device is worn but inactive and compared to the sleep efficiency for each day 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.
Time Frame
At the completion of the study (14 days), including at least 4 days in each block.
Title
Sleep Onset Latency After Wake After Sleep Onset Events (WASO) During Sham Stimulation Sessions Compared to Active Stimulation Sessions
Description
Sleep onset latency will be measured after middle-of-night wake up events using EEG-based metrics according to guidelines set forth by the American Academy of Sleep Medicine (AASM). Stimulation condition (sham or active) will be randomized for each WASO event (including events within a single night as well as across all nights). At the completion of the study, SOL will be compared for WASO events in which sham stimulation was delivered compared to WASO events in which active stimulation was delivered.
Time Frame
At the completion of the study (7-14 days).
Title
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Description
Subject-reported time to fall asleep will be assessed using the results from a questionnaire that includes the first 9 questions from the Consensus Sleep Diary (Carney et al., 2012). This survey asks the participant to report bed time, wake time, the amount of time it took to fall asleep, the number of awakenings during the night and the total duration of such awakenings. The questionnaire also asks the subject to rate quality of sleep on a 5-point scale from very poor to very good. The reported time to fall asleep on days during the sham block will be compared to the same metric reported on days during the stimulation block.
Time Frame
At the completion of the study (14 days).
Title
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
Description
Subject-reported feelings of sleepiness and alertness during the day will be assessed using the Karolinska Sleepiness Scale (KSS) questionnaire. This is a single question scale on which sleepiness is assessed using a score from 1-9, with 1 representing a level of high alertness, and 9 representing very sleepy. The reported KSS score during the sham block will be compared to the same metric reported on days during the stimulation block.
Time Frame
At the completion of the study (14 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Neely, PhD
Phone
734-355-7131
Email
ryan.neely@elemindtech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Bressler, PhD
Email
scott.bressler@elemindtech.com
Facility Information:
Facility Name
Elemind Technologies, Inc
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Yost
Email
ryan.yost@elemindtech.com
First Name & Middle Initial & Last Name & Degree
Ryan Neely, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

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

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