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. 2023 Jan 18:12:27536130221147475.
doi: 10.1177/27536130221147475. eCollection 2023 Jan-Dec.

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

Catherine L Tegeler  1 , Heidi Munger Clary  1 , Hossam A Shaltout  2 , Sean L Simpson  3 , Lee Gerdes  4 , Charles H Tegeler  1
Affiliations

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

Catherine L Tegeler et al. Glob Adv Integr Med Health. .

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.

Keywords: Cereset Research; HIRREM; acoustic neuromodulation; allostasis; autonomic; closed loop neurotechnology; insomnia.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors affiliated with the Wake Forest School of Medicine have no conflicts to report. Lee Gerdes is currently employed by Brain State Technologies, Scottsdale, AZ.

Figures

Figure 1.
Figure 1.
Study overview demonstrating timeline for visits, intervention/control delivery, and outcome collection during the randomized (V1-3) and crossover portions of the study (V4-5).
Figure 2.
Figure 2.
Consort diagram showing the flow of participants through the study for the groups receiving tones linked to brainwaves (LB, intervention), and tones not linked to brainwaves (NL, control).
Figure 3.
Figure 3.
A. Intention to Treat outcomes for the Insomnia Severity Index (ISI) at baseline (V1), 0-14 days post randomized intervention/control (V2), 4-6 weeks after completion of randomized intervention/control (V3, primary outcome) for those receiving intervention (tones linked to brainwaves, LB) compared to control (tones not linked to brainwaves, NL) B. Crossover outcomes for ISI among N = 6 participants randomized to control who subsequently received active intervention. V4 occurred 0-14 days post active intervention completion and V5 occurred 4-6 weeks post active intervention completion (*P ≤ .05, **P ≤ .01, ***P ≤ .001 for comparison to V1 baseline value).
Figure 4.
Figure 4.
Panel of 3 autonomic function measures: Seq ALL, a measure of baroreflex sensitivity, and 2 heart rate variability outcome measures, rMSSD and SDNN. Results are shown for the randomized portion of the study (Figure 4A-C) and crossover portion (Figure 4D-F). Results shown include change within groups over time compared to V1 for those receiving tones linked to brainwaves (LB intervention) and tones not linked to brainwaves (NL control;. * = P < .05, ** = P < .01), differences between the 2 groups during the randomized portion of the study (# = P < .05, ## = P < .01), and difference from V3 in the crossover portion ($ = P < .05).
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