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Abstract Objective Effective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham‐controlled trial of Cereset Research™ Standard Operating Procedures (CR‐SOP), a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia. Methods Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self‐report measures of sleep, mood, and anxiety. Results Participants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P |
