Moderate to Severe InsomniaNCT07659366
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
A study testing Transcranial alternating current stimulator in people with Moderate to Severe Insomnia, run by Nexalin Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Insomnia
- What is being tested?
- Transcranial alternating current stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2027to 25 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
The HALO Clarity™ Transcranial Alternating Current Stimulation Therapy for Adults with Moderate-to-Severe Insomnia trial is a prospective, decentralized, individually-randomized, triple-blind, sham-controlled superiority study evaluating the safety and efficacy of the HALO Clarity™ device in adults with moderate-to-severe insomnia.
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 device consists of a lightweight wearable headset with three dry electrodes (one forehead and two mastoid) connected via Bluetooth to a dedicated mobile application. The application guides users through treatment sessions, monitors electrode contact quality, displays remaining treatment time, and automatically logs usage data.
This trial employs a fully decentralized (remote/virtual) design to evaluate the device under conditions consistent with its intended real-world use. All study activities-including informed consent, pre-screening, screening, clinical evaluation, randomization, device shipment to the participant's home, treatment, and follow-up assessments-are conducted remotely without requiring in-person clinic visits. This approach reduces participant burden, expands geographic access, and maintains high data quality through centralized electronic data capture systems and structured remote clinician oversight.
The study uses a 1:1 randomized, triple-blind, sham-controlled design. Participants, clinical site personnel (including investigators), and study researchers responsible for outcome assessment remain blinded to treatment allocation throughout the trial. The sham device is physically identical to the active device in appearance, weight, electrode placement, vibration feedback, and mobile application interface. However, the sham device delivers a non-therapeutic modulation scheme consisting of brief ramp-up and ramp-down pulses designed to provide a similar initial sensory experience while lacking the sustained neuromodulatory effect of the active 77.5 Hz waveform. This sham design supports maintenance of participant blinding while allowing estimation of the specific treatment effect attributable to the active stimulation. Eligible participants are adults aged 22 to 65 years with moderate-to-severe insomnia, defined as an Insomnia Severity Index (ISI) total score of 15 or greater.
The treatment period consists of one 40-minute 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 of the participant's intended bedtime. Treatment compliance is automatically recorded via the device and application. After completing the four-week treatment period, all participants enter a four-week post-treatment follow-up period to assess durability of effect.
The primary endpoint is the mean total ISI score at four weeks after treatment initiation, comparing participants assigned to the active device versus those assigned to the sham device. Key secondary endpoints include ISI score at eight weeks (durability), Pittsburgh Sleep Quality Index (PSQI) scores at four and eight weeks, and Short Form-36 (SF-36) health-related quality of life scores at four and eight weeks. Exploratory endpoints include changes in PHQ-9 depression scores, GAD-7 anxiety scores, and the proportion of participants achieving a clinically meaningful improvement (reduction of ≥6 points) on the By evaluating the HALO Clarity™ device in a rigorous, sham-controlled, decentralized trial, this study aims to generate high-quality evidence regarding its safety and efficacy as a non-pharmacological treatment for moderate-to-severe insomnia. If successful, the device could offer a convenient, home-based treatment option that addresses unmet needs in the current insomnia treatment landscape.
- Conditions
- Moderate to Severe Insomnia
- Being tested
- Transcranial alternating current stimulator
- Keywords
- Insomnia, tACS, cranial electrotherapy stimulator device, Transcranial Alternating Current Stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulatorDevice
Also called Active Arm Intervention Name: HALO Clarity™ Active Device., Sham Arm Intervention Name: HALO Clarity™ Sham 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial alternating current stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks after treatment initiation.
Secondary outcomes (3)
Insomnia Severity Index (ISI) Total Score at Week 8
Mean total ISI score at 8 weeks after treatment initiation (4 weeks after completion of the intervention). Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks [Time Frame: baseline and end of each four-week intervention] The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia
Measured: 8 weeks after treatment initiation
Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 4 and 8
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality in both groups. The PSQI is a self-reported questionnaire that measures sleep quality and disturbances over a 1-month time interval. It yields a global score ranging from a minimum of 0 to a maximum of 21, where higher scores indicate worse sleep quality (a score greater than 5 indicates severe difficulties in at least two areas, or moderate difficulties in more than three areas).
Measured: 4 weeks and 8 weeks after treatment initiation
Short Form-36 Health Survey (SF-36) Score at Weeks 4 and 8
Mean score on the Short Form-36 Health Survey (SF-36) at 4 and 8 weeks. Mean score on the Short Form-36 Health Survey (SF-36), a validated 36-item questionnaire measuring health-related quality of life (domain and component summary scores each range from 0 [worst health-related quality of life] to 100 [best health-related quality of life]; higher scores indicate better health-related quality of life), at 4 and 8 weeks after treatment initiation in participants assigned to the active HALO Clarity™ device compared with those assigned to the sham device.
Measured: 4 weeks and 8 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start30 Jan 2027 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion25 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexalin Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curavit Clinical Research
- Responsible party
- Sponsor
- Investigators
- David Owens, M.D., Principal investigator, Nexalin Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659366
- Sponsor's protocol ID
- IRB Tracking Number: 20261960
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan at this time to share individual participant data from this clinical trial.
Publications
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.
PubMed 36115372Wang 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.
PubMed 31846980Wang 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.
PubMed 35353887Zhu 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.
PubMed 38176353
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07659366
- Acronym / sponsor ID
- IRB Tracking Number: 20261960
- Conditions
- Moderate to Severe Insomnia
- Keywords
- Insomnia, tACS, cranial electrotherapy stimulator device, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nexalin TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Curavit Clinical Research
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 25 Oct 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HALO Clarity™ Transcranial Alternating Current Stimulation Therapy for Adults with Moderate-to-Severe Insomnia trial is a prospective, decentralized, individually-randomized, triple-blind, sham-controlled superiority study evaluating the safety and efficacy of the HALO Clarity™ device in adults with moderate-to-severe insomnia.
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 device consists of a lightweight wearable headset with three dry electrodes (one forehead and two mastoid) connected via Bluetooth to a dedicated mobile application. The application guides users through treatment sessions, monitors electrode contact quality, displays remaining treatment time, and automatically logs usage data.
This trial employs a fully decentralized (remote/virtual) design to evaluate the device under conditions consistent with its intended real-world use. All study activities-including informed consent, pre-screening, screening, clinical evaluation, randomization, device shipment to the participant's home, treatment, and follow-up assessments-are conducted remotely without requiring in-person clinic visits. This approach reduces participant burden, expands geographic access, and maintains high data quality through centralized electronic data capture systems and structured remote clinician oversight.
The study uses a 1:1 randomized, triple-blind, sham-controlled design. Participants, clinical site personnel (including investigators), and study researchers responsible for outcome assessment remain blinded to treatment allocation throughout the trial. The sham device is physically identical to the active device in appearance, weight, electrode placement, vibration feedback, and mobile application interface. However, the sham device delivers a non-therapeutic modulation scheme consisting of brief ramp-up and ramp-down pulses designed to provide a similar initial sensory experience while lacking the sustained neuromodulatory effect of the active 77.5 Hz waveform. This sham design supports maintenance of participant blinding while allowing estimation of the specific treatment effect attributable to the active stimulation. Eligible participants are adults aged 22 to 65 years with moderate-to-severe insomnia, defined as an Insomnia Severity Index (ISI) total score of 15 or greater.
The treatment period consists of one 40-minute 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 of the participant's intended bedtime. Treatment compliance is automatically recorded via the device and application. After completing the four-week treatment period, all participants enter a four-week post-treatment follow-up period to assess durability of effect.
The primary endpoint is the mean total ISI score at four weeks after treatment initiation, comparing participants assigned to the active device versus those assigned to the sham device. Key secondary endpoints include ISI score at eight weeks (durability), Pittsburgh Sleep Quality Index (PSQI) scores at four and eight weeks, and Short Form-36 (SF-36) health-related quality of life scores at four and eight weeks. Exploratory endpoints include changes in PHQ-9 depression scores, GAD-7 anxiety scores, and the proportion of participants achieving a clinically meaningful improvement (reduction of ≥6 points) on the By evaluating the HALO Clarity™ device in a rigorous, sham-controlled, decentralized trial, this study aims to generate high-quality evidence regarding its safety and efficacy as a non-pharmacological treatment for moderate-to-severe insomnia. If successful, the device could offer a convenient, home-based treatment option that addresses unmet needs in the current insomnia treatment landscape.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Active HALO Clarity™ Device | Active comparator | Device: Transcranial alternating current stimulatorParticipants 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. |
| Arm 2: Sham HALO Clarity™ Device | Sham comparator | Device: Transcranial alternating current stimulatorParticipants 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating current stimulatorAlso: Active Arm Intervention Name: HALO Clarity™ Active Device., Sham Arm Intervention Name: HALO Clarity™ Sham DeviceThe 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). | Device | Arm 1: Active HALO Clarity™ Device, Arm 2: Sham HALO Clarity™ Device |
Primary outcome
Change in Insomnia Severity Index (ISI) Total Score at Week 4
Time frame: 4 weeks after treatment initiation.
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).
3 secondary outcomes
Insomnia Severity Index (ISI) Total Score at Week 8
Time frame: 8 weeks after treatment initiation
Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 4 and 8
Time frame: 4 weeks and 8 weeks after treatment initiation
Short Form-36 Health Survey (SF-36) Score at Weeks 4 and 8
Time frame: 4 weeks and 8 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 36115372Perlis 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.
- Background: PubMed 31846980Wang 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.
- Background: PubMed 35353887Wang 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.
- Background: PubMed 38176353Zhu 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.
- Individual participant dataSharing planned: No. There is no plan at this time to share individual participant data from this clinical trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Owens, M.D. principal investigator
Nexalin Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulator in people with Moderate to Severe Insomnia, run by Nexalin Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Shelton (+1 832-260-0222, carolyn@nexalin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Total Score at Week 4 (time frame: 4 weeks after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07659366, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.