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We report the results of randomized, sham\u2010controlled trial of Cereset Research\u2122 Standard Operating Procedures (CR\u2010SOP), a noninvasive, closed\u2010loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score \u226523) after mTBI 3\u2009months to 10\u2009years 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\u2010report measures of sleep, mood, and anxiety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Participants (<jats:italic>n<\/jats:italic>\u2009=\u2009106, 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 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001), with gains largely sustained at 3\u2009months (31.2) and 6\u2009months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post\u2010intervention, 31.5 at 3\u2009months, and 29.4 at 6\u2009months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ\u20109 and there was no difference in HRV between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Ten hours of acoustic stimulation while resting in a zero\u2010gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones.<\/jats:p><jats:p>Registration: ClinicalTrials.gov \u2013 NCT03649958<\/jats:p><\/jats:sec>","DOI":"10.1002\/acn3.51937","type":"journal-article","created":{"date-parts":[[2023,11,23]],"date-time":"2023-11-23T23:51:02Z","timestamp":1700783462000},"page":"105-120","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms"],"prefix":"10.1002","volume":"11","author":[{"given":"Wesley R.","family":"Cole","sequence":"first","affiliation":[{"name":"University of North Carolina  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2943-6719","authenticated-orcid":false,"given":"Catherine L.","family":"Tegeler","sequence":"additional","affiliation":[{"name":"Wake Forest School of Medicine  Winston\u2010Salem North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y. 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