Summary: HIRREM, a closed-loop acoustic stimulation neurotechnology, reduced insomnia symptoms, and improved autonomic nervous system function.
Source: Wake Forest Baptist Medical Center
For people with chronic insomnia, a good night’s sleep is elusive. But what if insomnia symptoms could be alleviated by simply listening to one’s own brainwaves?
Researchers at Wake Forest Baptist Health conducted a clinical trial that showed reduced insomnia symptoms and improved autonomic nervous system function using a closed-loop, acoustic stimulation neurotechnology. The study is published in the September 17 online edition of the journal Brain and Behavior.
High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM) uses scalp sensors to monitor brainwaves and software algorithms to translate specific frequencies into audible tones of varying pitch in real time.
These tones linked to brainwaves are echoed back instantaneously via ear buds. This allows the brain a chance to listen to itself, to look at itself in an acoustic mirror.
“Sleep is foundational for optimal health, healing and well-being,” said principal investigator Charles H. Tegeler, M.D., chair of neurology at Wake Forest School of Medicine, part of Wake Forest Baptist Health.
“HIRREM is a unique non-drug, noninvasive, acoustic neuromodulation intervention that supports the brain to balance and quiet itself. Our results show durable benefit for both reduced symptoms of insomnia and significantly improved objective measures of autonomic function.”
HIRREM technology supports the brain to self-adjust, to reset from what may have become stuck trauma and stress patterns, believed to contribute to insomnia, Tegeler said. The brain pattern is observed to shift toward improved balance and reduced hyperarousal with no conscious, cognitive activity required.
According to the American Academy of Sleep Medicine, about 30 to 35% of Americans have experienced insomnia, which can reduce life expectancy and increase the risk of cardiovascular events, obesity, diabetes and other illnesses.
The study included 107 adult men and women with moderate to severe insomnia. Approximately half received the HIRREM intervention, and the placebo group received an active intervention of random tones. All participants kept a daily sleep diary, and each received 10, 60-minute intervention sessions (either HIRREM or placebo), over a three-week period.
In the study, changes were recorded on the Insomnia Severity Index (ISI), a self-reporting instrument to assess insomnia symptoms. Researchers also recorded heart rate and blood pressure to objectively analyze autonomic cardiovascular regulation.
After completion of the intervention sessions and at follow-up visits up to four months later, subjects in the HIRREM group reported clinically meaningful reductions for insomnia symptoms. Four months following the intervention, 78% of those receiving HIRREM reported no significant insomnia symptoms. They also showed significant, durable improvements in autonomic function across multiple objective measures of heart rate variability (HRV) and baroreflex sensitivity (BRS) compared to those who received random tones. HRV is a powerful biometric that reflects the health of the autonomic nervous system, and BRS measures blood pressure regulation.
In this study, the HIRREM participants were five times more likely than placebo to have improvement in their HRV measured as rMSSD by more than 50%. They were also twice as likely to have improved BRS by more than 50% compared to placebo.
These changes may lead to long-term improvement in the cardiovascular health of the participants, Tegeler said. There were no serious adverse events, and less than 6% of study participants dropped out.
“These findings add to the rapidly growing interest in neuromodulation and demonstrate that a brief intervention with closed-loop acoustic stimulation can improve sleep in a meaningful way, while also improving autonomic function,” Tegeler said. “It’s an important alternative approach for people who suffer from insomnia.”
Funding: This study was supported by a research grant from The Susanne Marcus Collins Foundation, Inc.
HIRREM, the legacy technology of Cereset, was developed and licensed by Brain State Technologies of Scottsdale, Ariz.
High‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo‐controlled clinical trial
Introduction Effective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM®), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology, to support self‐optimization of brain rhythms.
Methods One hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90‐min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1–7 days (V2), 8–10 weeks (V3), and 16–18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ‐5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS).
Results Of 107 randomized, 101 completed the intervention. Intention‐to‐treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of −4.93 (SE ± 0.76) points, with additional, significant reduction of −2.05 points (0.74) in LB (total reduction of −6.98, p = .045). Additional reduction of −2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was −5.90 points for NL and −7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events.
Conclusions Results of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.