High‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo‐controlled clinical trial
| Autor: | Lee Gerdes, Charles H. Tegeler, Hossam A. Shaltout, Sung W. Lee, Sean L. Simpson, Catherine L. Tegeler |
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| Rok vydání: | 2020 |
| Předmět: |
closed‐loop neurotechnology
Adult medicine.medical_specialty insomnia Autonomic Nervous System Placebo lcsh:RC321-571 Behavioral Neuroscience Quality of life Heart Rate Sleep Initiation and Maintenance Disorders Internal medicine Insomnia Humans Medicine Heart rate variability lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry Original Research autonomic business.industry Baroreflex Middle Aged HIRREM Clinical trial Treatment Outcome Quality of Life Cardiology Anxiety Female Sleep diary allostasis Sleep onset latency medicine.symptom acoustic neuromodulation business |
| Zdroj: | Brain and Behavior Brain and Behavior, Vol 10, Iss 11, Pp n/a-n/a (2020) |
| ISSN: | 2162-3279 |
| DOI: | 10.1002/brb3.1826 |
| Popis: | 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 This controlled clinical trial observed significant added benefit to reduce symptoms of insomnia with use of a closed‐loop, acoustic stimulation neurotechnology that echoes tones linked to brainwaves (HIRREM), compared to a sham using randomly generated tones. There was also significant improvement in multiple measures of autonomic cardiovascular regulation, with durability to 4 months postintervention, and group differences for sleep efficiency, total sleep time, and sleep onset latency. Results suggest that this noninvasive, nondrug intervention could provide a viable alternative for moderate to severe insomnia. |
| Databáze: | OpenAIRE |
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