Cereset Research Standard Operating Procedures for Insomnia: A Randomized, Controlled Clinical Trial

Abstract

Background Interventions for insomnia that also address autonomic dysfunction are needed. Objective We evaluate Cereset Research™ Standard Operating Procedures (CR-SOP) in a pilot randomized, controlled trial. CR-SOP is a less operator-dependent, more generalizable innovation of HIRREM®, a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology demonstrated to improve insomnia and autonomic function. Methods Adults with Insomnia Severity Index (ISI) scores of ≥8 were randomized to receive ten sessions of CR-SOP, with tones linked to brainwaves (LB, intervention), or a sham condition of random tones not linked to brainwaves (NL, control). Measures were collected at enrollment and 0-14 days and 4-6 weeks post-allocated intervention. The primary outcome was differential change in ISI from baseline to 4-6 weeks post-intervention. Secondary self-report measures assessed sleep quality65 and behavioral outcomes. Ten-minute recordings of heart rate and blood pressure were collected to analyze autonomic function (heart rate variability [HRV] and baroreflex sensitivity). Results Of 22 randomized, 20 participants completed the allocated condition. Intention to treat analysis of change from baseline to the 4-6 week outcome demonstrated mean ISI score reduction of 4.69 points among controls (SE 1.40). In the intervention group, there was an additional 2.58 point reduction in ISI score (SE 2.13; total reduction of 7.27, P = .24). Sleep quality and some measures of autonomic function improved significantly among the intervention group compared to control. Conclusions This pilot study compared use of a standardized, allostatic, acoustic neurotechnology intervention with a sham, active control condition. The magnitude of change in insomnia severity was clinically relevant and similar to the findings in a prior, fully powered trial, but the differential improvement observed was not statistically significant. Significant improvements were demonstrated in sleep quality and some autonomic function measures.

Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms

“…The intervention group in both studies also demonstrated clinically relevant improvement, whereas the sham groups did not. In the CR‐SOP insomnia study, not only did sleep quality improve, but some measures of autonomic function improved significantly among the intervention group compared to control 31 . These studies, taken with the results of the current study, suggest the impact of the common elements between the allocation groups, notably 10 h of relaxation facilitated by a zero gravity chair and computer‐generated auditory tones, shows statistically significant changes from pre‐intervention.…”

“…The fact that the overall study population showed such marked and sustained improvement indicates that study participation, which included relaxation via resting in a comfortable, zero‐gravity chair with eyes closed in dim light while listening to engineered auditory tones, is therapeutic. Two previously published studies evaluating legacy HIRREM 30 and CR‐SOP 31 for insomnia found improvement in both allocation groups, though the active intervention group had statistically significant larger improvement than the sham group. The intervention group in both studies also demonstrated clinically relevant improvement, whereas the sham groups did not.…”

“…All interactions, procedures, sensor placements, and session times for NL mirrored the intervention LB condition. A more detailed description of the CR‐SOP intervention has been published 31 …”

“…Application of CR with computer algorithm standard operating procedure (CR-SOP) eliminates the potential for human error and improves speed in translating and reflecting brainwaves as tones. 31 The objective of our study was to evaluate the efficacy of CR-SOP in reducing symptoms that persist at least 3 months after injury. We hypothesized that 10 sessions of CR-SOP would result in greater self-reported symptom reduction than 10 sessions of sham nonspecific acoustic stimulation, and that these gains would persist at least 3 months post-intervention.…”

“…This technology is available commercially as a general wellness device for relaxation, well‐being, and stress management, and has an FDA exemption. Application of CR with computer algorithm standard operating procedure (CR‐SOP) eliminates the potential for human error and improves speed in translating and reflecting brainwaves as tones 31 …”