HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia: A Prospective, Individually-Randomized, Triple-Blind, Sham-Controlled, Decentralized, Superiority Trial

Conditions

• Moderate to Severe Insomnia

Eligibility Criteria

Sex

ALL

Age

22 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Device: 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. The waveform is charge-balanced with no net direct current. The device consists of a wearable headset with three dry electrodes (one positioned on the forehead and two on the mastoid regions behind the ears). The headset connects via Bluetooth to a dedicated mobile application that controls treatment initiation, monitors electrode contact quality, displays session progress, and records usage data. Participants self-administer one 40-minute treatment session per day, five days per week, for four consecutive weeks (maximum of 20 sessions). Sessions may be performed at any time of day except within three hours before the participant's intended bedtime.

Study Details

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.

Key Dates

Start date

Jun 22, 2026

Status verified

Jun 2026

Primary completion

Jul 1, 2027

Completion

Oct 25, 2027

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1: Active HALO Clarity™ Device
  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.
• Sham Comparator: Arm 2: Sham HALO Clarity™ Device
  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.

Primary Outcome Measure

Change in Insomnia Severity Index (ISI) Total Score at Week 4 [ Time Frame: 4 weeks after treatment initiation. ]

Central Contacts

• Carolyn Shelton
  +1 832-260-0222
  [email protected]
• Priscilla Nechrebecki, MHA
  +1 913-777-4189
  [email protected]

Locations (1)

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