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

NCT07659366 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB Tracking Number: 20261960
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate to Severe Insomnia

Keywords

Insomnia; tACS; cranial electrotherapy stimulator device; Transcranial Alternating Current Stimulation

Outcome Measures

Primary Outcomes (1)

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

  Mean total score on the Insomnia Severity Index (ISI) at 4 weeks after treatment initiation in participants assigned to the active HALO Clarity™ device compared with those assigned to the sham device. The analysis will estimate the between-group difference in mean ISI total score, adjusting for baseline ISI score. The ISI is a validated 7-item participant-reported outcome measure assessing perceived insomnia severity, with total scores ranging from 0 to 28 (higher scores indicate greater insomnia severity).

  4 weeks after treatment initiation.

Secondary Outcomes (3)

• Insomnia Severity Index (ISI) Total Score at Week 8

  8 weeks after treatment initiation

• Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 4 and 8

  4 weeks and 8 weeks after treatment initiation

• Short Form-36 Health Survey (SF-36) Score at Weeks 4 and 8

  4 weeks and 8 weeks after treatment initiation

Other Outcomes (2)

• Patient Health Questionnaire-9 (PHQ-9) Score at Weeks 4 and 8

  4 weeks and 8 weeks after treatment initiation

• Generalized Anxiety Disorder-7 (GAD-7) Score at Weeks 4 and 8

  4 weeks and 8 weeks after treatment initiation

Study Arms (2)

Arm 1: Active HALO Clarity™ Device

ACTIVE COMPARATOR

Participants randomized to this arm will receive the active HALO Clarity™ device. The device delivers a proprietary alternating current waveform with an amplitude of 15 mA RMS, modulated at 77.5 Hz with a 100 kHz carrier frequency. Participants will self-administer one 40-minute treatment session per day, 5 days per week, for 4 weeks (up to 20 sessions total) using the device at home.

Device: Transcranial alternating current stimulator

Arm 2: Sham HALO Clarity™ Device

SHAM COMPARATOR

Participants randomized to this arm will receive a sham HALO Clarity™ device. The sham device is physically identical to the active device in appearance, hardware, electrode placement, and mobile application interface. However, it delivers a non-therapeutic modulation scheme (brief ramp-up and ramp-down pulses) designed to provide a similar sensory experience while lacking therapeutic neuromodulatory effect. Participants will self-administer one 40-minute treatment session per day, 5 days per week, for 4 weeks (up to 20 sessions total) using the device at home.

Device: Transcranial alternating current stimulator

Interventions

Transcranial alternating current stimulator DEVICE

The HALO Clarity™ Device is a non-invasive cranial electrotherapy stimulator designed for at-home use. It delivers a proprietary alternating current waveform with an amplitude of 15 mA RMS, modulated at 77.5 Hz and superimposed on a 100 kHz carrier frequency. Participants self-administer one 40-minute treatment session per day, five days per week, for four consecutive weeks (maximum of 20 sessions).

Also known as: Active Arm Intervention Name: HALO Clarity™ Active Device., Sham Arm Intervention Name: HALO Clarity™ Sham Device

Arm 1: Active HALO Clarity™ Device; Arm 2: Sham HALO Clarity™ Device

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 medications may be started during the trial).

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Presence of a current medical condition that, in the opinion of the Investigator or delegate, could impair reliable participation in the study or require the use of prohibited medications.
• Use of any form of electronic brain stimulation or neuromodulation within the past 1 year (including cranial electrotherapy stimulation \[CES\], transcranial magnetic stimulation \[TMS\], electroconvulsive therapy \[ECT\], or deep brain stimulation).
• Institutionalization for a mental health condition within 1 year prior to study entry.
• Current or history of alcohol or drug abuse or dependence within the past 5 years.
• Under medical supervision for a serious medical condition (including, but not limited to, intracranial tumors or aneurysm).
• Suspected or known history of heart disease.
• Implanted electronic device (e.g., pacemaker, defibrillator, deep brain stimulator, or cochlear implant).
• History of seizures or epilepsy.
• History or current diagnosis of a chronic pain condition and/or use of opioids for any reason within the past 3 months.
• Use of recreational drugs, hypnotics, anabolic steroids, or marijuana products within the past 30 days, or planned use during the study (stable use of CBD is permitted).
• Females who are currently pregnant or planning to become pregnant during study participation.
• Current participation in another investigational study, or participation in an investigational study within the past 30 days.
• Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study.

Sponsors & Collaborators

• Nexalin Technology: lead
• Lindus Health: collaborator

Study Sites (1)

Nexalin Technology

Houston, Texas, 77056, United States

Location

Related Publications (4)

• Perlis ML, Posner D, Riemann D, Bastien CH, Teel J, Thase M. Insomnia. Lancet. 2022 Sep 24;400(10357):1047-1060. doi: 10.1016/S0140-6736(22)00879-0. Epub 2022 Sep 14.

  PMID: 36115372 BACKGROUND

• Wang HX, Wang L, Zhang WR, Xue Q, Peng M, Sun ZC, Li LP, Wang K, Yang XT, Jia Y, Zhou QL, Xu ZX, Li N, Dong K, Zhang Q, Song HQ, Zhan SQ, Min BQ, Fan CQ, Zhou AH, Guo XH, Li HB, Liang LR, Yin L, Si TM, Huang J, Yan TY, Cosci F, Kamiya A, Lu J, Wang YP. Effect of Transcranial Alternating Current Stimulation for the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial. Psychother Psychosom. 2020;89(1):38-47. doi: 10.1159/000504609. Epub 2019 Dec 17.

  PMID: 31846980 BACKGROUND

• Wang H, Wang K, Xue Q, Peng M, Yin L, Gu X, Leng H, Lu J, Liu H, Wang D, Xiao J, Sun Z, Li N, Dong K, Zhang Q, Zhan S, Fan C, Min B, Zhou A, Xie Y, Song H, Ye J, Liu A, Gao R, Huang L, Jiao L, Song Y, Dong H, Tian Z, Si T, Zhang X, Li X, Kamiya A, Cosci F, Gao K, Wang Y. Transcranial alternating current stimulation for treating depression: a randomized controlled trial. Brain. 2022 Mar 29;145(1):83-91. doi: 10.1093/brain/awab252.

  PMID: 35353887 BACKGROUND

• Zhu X, Ren Y, Tan S, Ma X. Efficacy of transcranial alternating current stimulation in treating chronic insomnia and the impact of age on its effectiveness: A multisite randomized, double-blind, parallel-group, placebo-controlled study. J Psychiatr Res. 2024 Feb;170:253-261. doi: 10.1016/j.jpsychires.2023.12.037. Epub 2023 Dec 29.

  PMID: 38176353 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• David Owens, M.D.

  Nexalin Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Shelton

CONTACT

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

Priscilla Nechrebecki, MHA

CONTACT

+1 913-777-4189; pri.nechrebecki@lindushealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 25, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)