Nexalin Advances Pivotal 160-Participant HALO Clarity Insomnia Trial for De Novo FDA Pathway
Nexalin Technology will launch a 160-participant, triple-blinded, sham-controlled pivotal trial of its HALO Clarity device in Q2 2026 to underpin a De Novo FDA submission for moderate-to-severe insomnia. Lindus Health will oversee protocol finalization through database lock, supporting potential entry in a sleep tech market projected at $153.7B by 2035.
1. Trial Design and Objectives
The planned pivotal study will enroll 160 participants in a randomized, triple-blinded, sham-controlled format to assess safety and efficacy of the HALO Clarity device for moderate-to-severe insomnia, with patient enrollment slated to begin in Q2 2026.
2. FDA De Novo Submission Strategy
Data from this trial are intended to support a De Novo Classification Request with the FDA, aiming to establish HALO Clarity as a distinct medical device category and differentiate it from existing neurostimulation therapies.
3. Partnership with Lindus Health
Lindus Health, as an Accountable Research Organization, will manage full trial execution, including protocol finalization, regulatory and ethics submissions, patient recruitment oversight, data management, biostatistics and medical writing through database lock.
4. Market Opportunity
The global sleep technology market stood at $29.3 billion in 2025 and is projected to grow to $153.7 billion by 2035, underscoring significant demand for innovative, non-pharmacologic insomnia treatments.