Not Yet RecruitingNot Applicable

HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia

United States160 participantsStarted 2026-06-22

Plain-language summary

A prospective, decentralized, individually-randomized, triple-blind\* sham-controlled, superiority trial to evaluate the safety and efficacy of HALO Clarity™ device in reducing insomnia severity. Participants will be randomized to Active and Sham device arms for four (4) weeks. After 4 weeks of treatment, all participants will be followed for an additional 4 weeks.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Participants must meet all of the following criteria to be eligible for the study: * Provide written informed consent prior to any study-related procedures. * Age between 22 and 65 years, inclusive. * Total score on the Insomnia Severity Index (ISI) of ≥15 at screening, indicating moderate-to-severe insomnia. * Participant-reported diagnosis of insomnia, confirmed by a licensed clinician during the remote clinical evaluation call. * Willingness to be randomized to either the active or sham device arm. * Agreement not to use any sleep tracking devices or applications (e.g., smartwatches, sleep apps) during the study. * Ability to read and write English at an 8th-grade level or higher. * Ability to receive packages at home via standard delivery services (United States Postal Service, FedEx, or UPS) in all U.S. states except Alaska and Hawaii. * Willing and able to use a personal internet-capable mobile device throughout the study for completing questionnaires, using the HALO Clarity™ App, and receiving study-related text messages. * Owns and is willing to communicate using a personal, verifiable email address. * Able and willing to commit to one 40-minute treatment session using the HALO Clarity™ device, 5 days per week for 4 weeks (up to 20 sessions total). * If currently using sleep medication, the regimen must have been stable for at least the past 3 months, with willingness to maintain the same medication and dosage throughout the study (no new sleep me…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insomnia Severity Index (ISI) Total Score at Week 4

Timeframe: 4 weeks after treatment initiation.

Trial details

NCT IDNCT07659366

SponsorNexalin Technology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Carolyn Shelton

+1 832-260-0222 carolyn@nexalin.com

View on ClinicalTrials.gov More Moderate to Severe Insomnia trials