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HALO Clarityâ„¢ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia

NCT07659366 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-06-23

No results posted yet for this study

Summary

A prospective, decentralized, individually-randomized, triple-blind\* sham-controlled, superiority trial to evaluate the safety and efficacy of HALO Clarityâ„¢ 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

Interventions

DEVICE

Transcranial alternating current stimulator

The HALO Clarityâ„¢ 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).

Sponsors & Collaborators

  • Lindus Health

    collaborator INDUSTRY

  • Nexalin Technology

    lead INDUSTRY

Principal Investigators

  • David Owens, M.D. · Nexalin Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2027-07-01
Completion
2027-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659366 on ClinicalTrials.gov