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Neuromodulation
Sound Therapy for Sleep Disorders (SLEEPFAST Trial)
N/A
Waitlist Available
Research Sponsored by Elemind Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subthreshold to Moderately severe Clinical insomnia (PSQI > 6)
Individuals that are not actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the completion of the study (7-14 days).
Awards & highlights
SLEEPFAST Trial Summary
This trial tests if sound can help people fall asleep faster by targeting brain waves.
Who is the study for?
This trial is for individuals who take 30 minutes or more to fall asleep and often wake up at night. They should have moderate insomnia symptoms, not be treated for certain psychological disorders with medications, and must understand English. Excluded are those with a BMI over 33, sleep apnea, neurological or psychiatric illness history, severe insomnia or anxiety disorder risk, substance abuse issues, metal implants in the brain or cardiac pacemakers.Check my eligibility
What is being tested?
The study tests if Elemind Neuromodulation (ENMod), which is auditory stimulation timed with brain waves during sleep onset as measured by EEG can help people fall asleep faster.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the EEG device during sleep and possible disturbances from the auditory stimulation.
SLEEPFAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have trouble sleeping, scoring over 6 on the PSQI.
Select...
I am not currently on medication for anxiety, insomnia, ADHD, or other mental health issues.
SLEEPFAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the completion of the study (7-14 days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the completion of the study (7-14 days).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Secondary outcome measures
Change in Sleep Efficiency During Sham Block Compared to Stimulation Block
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
+1 moreSLEEPFAST Trial Design
2Treatment groups
Experimental Treatment
Group I: Wake After Sleep OnsetExperimental Treatment1 Intervention
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).
Group II: Sleep Onset Latency CrossoverExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elemind Neuromodulation (ENMod)
2020
N/A
~200
Find a Location
Who is running the clinical trial?
Elemind Technologies, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You usually fall asleep in less than 30 minutes.You sleep well according to a sleep quality questionnaire (PSQI score less than 6).You have a very high risk for severe Generalized Anxiety Disorder, with a score of more than 15 on the GAD-7 questionnaire.You have a moderate to high risk for alcohol abuse.You usually take 30 minutes or more to fall asleep when you go to bed.I am currently taking medication for depression, ADHD, blood pressure, or using cannabis products.My insomnia is not severe, with an ISI score below 21.I am currently taking medication for anxiety, insomnia, ADHD, or another psychological disorder.I have severe insomnia.I have had seizures or there is a history of seizures in my family.Your weight is too high for your height.I have been diagnosed with apnea.I have or had a brain or mental health condition.You work overnight shifts on any night of the week.I have been diagnosed with hearing loss.I have trouble sleeping, scoring over 6 on the PSQI.You have a low risk for having severe Generalized Anxiety Disorder, which is measured by a score of less than 15 on the GAD-7 assessment.I have a history of migraines.You drink more than 4 cups of caffeinated beverages every day.You can't have any caffeine 6 hours before each recording session, including coffee, tea, and caffeinated sodas.I have had a brain injury or unexplained fainting.You have a cochlear implant in one or both ears.I am not currently on medication for anxiety, insomnia, ADHD, or other mental health issues.You have a pacemaker in your heart or metal implant in your head.You have trouble staying asleep and rate it as "Moderate," "Severe," or "Very Severe."You wake up in the middle of the night or early morning at least once a week.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Onset Latency Crossover
- Group 2: Wake After Sleep Onset
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study allow for the recruitment of participants under 25 years old?
"As determined by the criteria for enrollment, participants must be between 21 and 55 years old."
Answered by AI
Could you provide information regarding the availability of enrolment for this clinical trial?
"This medical experiment is registering participants, as detailed on clinicaltrials.gov which shows it was first registered on February 2nd 2020 and subsequently edited lastly on February 14th 2023."
Answered by AI
How many individuals are being enrolled in this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this medical experiment has been recruiting since February 2nd 2020 and requires 250 participants from a single site for completion. The study was last updated on February 14th 2023."
Answered by AI
Are there available slots in this trial for me to partake?
"This investigation is currently recruiting 250 people aged 21-55 who suffer from sleep issues. To be suitable, the prospective participants must provide written consent in English, take at least 30 minutes to fall asleep on average, present with subthreshold to moderately severe insomnia symptoms (ISI < 21), have a PSQI score higher than 6, GAD-7 lower than 15 and not use medications for psychological disorders such as anxiety or ADHD. Moreover they should report moderate to very severe difficulty staying asleep and awaken 1 or more times per week in the middle of the night/early morning."
Answered by AI
Who else is applying?
What site did they apply to?
Elemind Technologies, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've tried different methods of treating my sleep issues before (including a sleep apnea study, low doses of antidepressants that were supposed to help me calm down before sleep, therapy, and other things), but nothing helped so far. I am starting my PhD next Fall and am very worried that my sleep disorder will come in the way of me accomplishing my academic goals. I would be delighted to have a chance to learn more about my sleep patterns and hopefully fix my sleep issues for good.
PatientReceived 2+ prior treatments
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