Non-invasive Neurotechnology Reduces Symptoms of Insomnia and Improves Autonomic Nervous System Function

A good night’s sleep is crucial to health and well-being. Numerous research studies have shown that insomnia can increase the risk of cardiovascular events, obesity, diabetes and other illnesses.

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.

https://neurosciencenews.com/ans-insomnia-neurotech-22390/

 

Cereset Research Standard Operating Procedures for Insomnia: A Randomized Controlled Clinical Trial, 2023, Catherine L. Tegeler, BS et al

https://journals.sagepub.com/doi/10.1177/27536130221147475

 

Interesting, if they're not just adjusting their tests and results to get a desired outcome. I'd certainly wait for larger, better controlled studies before spending money on a unit.

I really strongly believe that it's unlikely to help with my ME-caused insomnia.