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

A vizsgálat adatai

Ki végzi

Nexalin Technology

Azonosító

NCT07659366

A regiszteradat frissítve

2026. október 30.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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: 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.

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.

Bevonási feltételek: 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).

Kizáró feltételek: 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; Implanted electronic device (e.g., pacemaker, defibrillator, deep brain stimulator, or cochlear implant); 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); 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; 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; 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; Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study; Participants who meet any of the following criteria will be excluded from the study:; 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.

ClinicalTrials.gov NCT07659366