Dataset Information

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.

SUBMITTER: Tegeler CL

PROVIDER: S-EPMC9933987 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature

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Publications

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

Tegeler Catherine L CL Munger Clary Heidi H Shaltout Hossam A HA Simpson Sean L SL Gerdes Lee L Tegeler Charles H CH

Global advances in integrative medicine and health 20230118

<h4>Background</h4>Interventions for insomnia that also address autonomic dysfunction are needed.<h4>Objective</h4>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<sup>®</sup>, a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology demonstrated to improve insomnia and autonomic function.<h4>Methods</h4>Adults with Insomnia Severity Index ...[more]

PMID: 36816469

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Dataset Information

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

Background

Objective

Methods

Results

Conclusions

Publications

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

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