Check Eligibility and Provide Consent
The HALO Trial: A clinical trial investigating a wearable headset device for the treatment of insomnia
This study aims to understand how the HALO Clarity - a headset device that sends gentle electrical signals - affects insomnia symptoms in comparison to an inactive (Sham) device.
If you qualify, you will receive up to $350 for your time. The study is fully remote, lasts approximately 12 weeks and involves a video call with a doctor, daily sleep diaries, weekly questionnaires and use of the HALO Clarity device at home. Twelve weeks covers 2-4 weeks of screening activities, 4 weeks using the headset and 4 weeks of follow-up.
The HALO Trial is launching this summer. Register your interest now!
Study overview
Your Participation
Here’s a step by step guide on what to expect:
Register your interest now, and a member of the trial team will contact you to check if you are eligible to participate.
Checking If You Are Eligible
To confirm your eligibility, you will answer questions about yourself, your health history, and your sleep. You will also confirm your ID with a secure identity verification system.
The verification process involves taking a photo of your ID and a selfie. Your personal information will only be used for this research study. Identity verification helps ensure the safety and integrity of the trial data.
After passing this pre-screening stage, you will be presented with a consent form to capture certain information that helps confirm your eligibility and interest in the study.
You will then be asked to complete 5 short questionnaires, about yourself, your sleep habits and your mental health. This will lead into a 2 week phase of daily sleep diaries that include questions about when you went to bed, when you woke up, and how rested you felt. You will need to complete the diary shortly after you wake up each morning, and it should take approx. 5 minutes to complete.
The final stage to confirm your eligibility will involve scheduling a video call with a licensed study doctor in which they will:
- Review your health history, sleep diaries and medications, and ask you questions about this.
- Confirm whether you qualify for the main study.
If you qualify you will attend a video call with a Lindus Health study team member where you will:
- Review the consent form including study requirements and eligibility criteria.
- Ask and receive answers to any questions you have about the study.
- Decide to sign the consent form.
- Confirm where to ship the headset device
- Be randomly assigned to either receive the Active device or the Sham Device (more information on this is provided in the main study’s informed consent form).
After signing the Main Study Consent Form you will move on to the next stages of the study, which include:
Baseline Questionnaires: These will take approximately 25 minutes to complete, and they can be completed at the same time or spread out, as long as they are completed before your headset arrives in the mail.
- A second Insomnia Severity Index (ISI)
- SF-36: 36 questions about your overall health and daily life
- PSQI: 19 questions about your sleep quality over the past month
- A second PHQ-9: 9 questions about your mood and feelings of depression
- A second GAD-7: 7 questions about worry and anxiety
Receiving Your Device
The HALO Clarity headset device will be mailed directly to your home. You will be given clear instructions on how to set it up and use it via the HALO Clarity App on your personal smartphone. The HALO Clarity App will be used to control the headset.
Treatment Period (Weeks 1–4)
Over four weeks, you will be asked to:
- Use the HALO Clarity headset at home for one 40-minute session per day, five days per week (up to 20 sessions in total), any time during the day except in the 3 hours before bedtime
- Complete a set of short online questionnaires covering your sleep, mood, anxiety, and quality of life. Some will be weekly and others every other week - these should take a maximum of 25 minutes each time
- Keep your sleep medications exactly the same as before the study - you must not start, stop, or change any sleep-related medication during the study
- Avoid using sleep trackers such as smartwatches, fitness bands, or sleep apps during the study. You may still wear these devices as long as you do not check sleep tracking or disable the sleep tracking feature.
Follow-Up Period (Weeks 5–8)
After the four-week treatment period ends, we will check in with you for a further four weeks. During this time:
- You will not be using the device
- You will continue to complete the same short surveys some weekly and some every other week
- This phase helps the research team understand whether any improvements in your sleep last after treatment ends
Compensation
Participants will receive up to $350 in total for completing the study
Timeline
The study runs for approximately 12 weeks: a 2-4 week screening and baseline period, 4 weeks of using the device, and a 4 week follow-up observation period
Study Site
The study is entirely remote with no in-person visits. Any contact with the study team will be via video, phone or email. The study device will be shipped to your home if you are eligible, and all assessments will be taken from your personal mobile device with an internet connection.
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Patient Stories
Who is this study for?
You may be eligible if you meet the following requirements:
Medical conditions
Do not have: a history of seizures or epilepsy, or a known or suspected heart condition, a serious medical condition currently being managed by a doctor
Pregnancy
Are not pregnant or planning to become pregnant during the study
Chronic pain
Do not have a history or current diagnosis of a chronic pain condition, and/or taking opioids for any reason in the last 3 months.
Between 22 and 65 years of age
Agree not to use any sleep tracking tools during the study (such as a sleep app, smartwatch, etc.)
Able and willing to use a personal phone with internet access throughout the study to fill out surveys, use the HALO Clarity App, and send/receive study-related emails and text messages
Able to commit to one (1) 40-minute session using the HALO Clarity headset 5 days a week for 4 weeks (up to 20 sessions total)
Only taking sleep medicine if you have been on the same dose for the last 3 months and are willing to stay on that same dose for the whole study without adding new medications
Have an implanted electronic device (e.g. pacemaker, defibrillator, cochlear implant, or deep brain stimulation device)
Have received any form of electrical or magnetic brain stimulation in the past year (e.g. cranial electrotherapy stimulation (CES), transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or deep brain stimulation)
Have been admitted to a mental health facility in the past year
Have had problems with alcohol or drug misuse in the past 5 years, or have used recreational drugs, sleeping pills, anabolic steroids, or cannabis products in the past 30 days or plan to during the study (a stable dose of CBD is okay)
Are currently taking part in another research study, or have done so in the past 30 days
Additional eligibility criteria will be reviewed during the screening process
Your questions answered
What is a clinical trial?
A clinical trial is a research study that helps develop and test new medical treatments, devices, or tests to determine if they are safe and effective. In this study, we are investigating whether the HALO Clarity device - a wearable headset that delivers gentle electrical stimulation - can help reduce insomnia symptoms. Your participation helps generate the evidence needed to understand whether this technology could benefit people with insomnia
Who is Nexalin Technology?
Nexalin Technology is looking to treat the mental health epidemic in the United States through the use of their Transcranial Alternating Current Stimulation (“tACS”) technique. By producing a patented frequency waveform that transmits an undetectable electric frequency, Nexalin seeks to stimulate a positive response in users' brains that may improve mental health issues.
Who is Lindus Health?
Lindus Health is a contract research organization (CRO) that manages clinical trials. We are responsible for the day-to-day running of this study, including participant support, data collection, and study coordination. Nexalin Technology is the study sponsor.
How long will my participation last?
If you are eligible, your total participation will be approximately 12 weeks, made up of a 2-4 week screening and baseline period, 4 weeks using the device, and 4 weeks of follow-up. The exact timing may vary slightly depending on device shipping.
Can I withdraw from the study?
Yes, at any time without penalty or effect on your medical care.
Accordion
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What is a clinical trial?
A clinical trial is a research study that helps develop and test new medical treatments, devices, or tests to determine if they are safe and effective. In this study, we are investigating whether the HALO Clarity device - a wearable headset that delivers gentle electrical stimulation - can help reduce insomnia symptoms. Your participation helps generate the evidence needed to understand whether this technology could benefit people with insomnia
Who is Nexalin Technology?
Nexalin Technology is looking to treat the mental health epidemic in the United States through the use of their Transcranial Alternating Current Stimulation (“tACS”) technique. By producing a patented frequency waveform that transmits an undetectable electric frequency, Nexalin seeks to stimulate a positive response in users' brains that may improve mental health issues.
Who is Lindus Health?
Lindus Health is a contract research organization (CRO) that manages clinical trials. We are responsible for the day-to-day running of this study, including participant support, data collection, and study coordination. Nexalin Technology is the study sponsor.
How long will my participation last?
If you are eligible, your total participation will be approximately 12 weeks, made up of a 2-4 week screening and baseline period, 4 weeks using the device, and 4 weeks of follow-up. The exact timing may vary slightly depending on device shipping.
Can I withdraw from the study?
Yes, at any time without penalty or effect on your medical care.