Key result
Ten sessions of CR-SOP acoustic stimulation resulted in a clinically relevant but statistically non-significant additional 2.58 point reduction in Insomnia Severity Index score compared to sham control (P = .24).
Why the study?
Interventions for insomnia that also address autonomic dysfunction are needed.
Does Cereset Research Standard Operating Procedures (CR-SOP) improve insomnia severity in adults with Insomnia Severity Index (ISI) scores of ≥8?
RCT (n=22)
Does Cereset Research Standard Operating Procedures (CR-SOP) improve insomnia severity in adults with Insomnia Severity Index (ISI) scores of ≥8?
Mean Difference: 2.58
Absolute Event Rate: 7.27% vs 4.69%
p-value: p=.24
CR-SOP showed clinically relevant but not statistically significant improvements in insomnia severity compared to sham, though sleep quality and some autonomic measures improved.
Supports CR-SOP for insomnia with autonomic benefits; extends prior HIRREM data but needs larger trials before adoption.
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.
No takes yet. Share an insight, caveat, or question.
Tegeler et al. (2023) conducted an RCT in Insomnia (n=22). Cereset Research Standard Operating Procedures (CR-SOP) vs. Sham condition of random tones not linked to brainwaves was evaluated on Differential change in ISI from baseline to 4-6 weeks post-intervention (MD 2.58, p=.24). Ten sessions of CR-SOP acoustic stimulation resulted in a clinically relevant but statistically non-significant additional 2.58 point reduction in Insomnia Severity Index score compared to sham control (P = .24).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: