High‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo‐controlled clinical trial

Tegeler, Catherine L.; Shaltout, Hossam A; Lee, Sung W.; Simpson, Sean L.; Gerdes, Lee; Tegeler, Charles H.

doi:10.1002/brb3.1826

Cited by 6 publications

(24 citation statements)

References 50 publications

(73 reference statements)

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“…Findings are in line with a previous randomized, controlled trial for insomnia. 19 CR-SOP is designed to decrease participant time burden with shorter, standardized sessions, and utilizes a less technologist-dependent approach. This study is an important step forward using a more reductionist approach that offers greater potential for scalability (ie less technologist training time and shorter participant listening time).…”

Section: Discussionmentioning

confidence: 99%

“…However, the magnitude and direction of change in insomnia, sleep quality, and many of the autonomic measures were similar to the benefit demonstrated in our prior larger trial. 19 …”

Section: Discussionmentioning

confidence: 99%

“…Continuous BP and HR were acquired from noninvasive finger BP cuff for a minimum of 10 minutes, with subjects lying down quietly, supine. Systolic BP (SBP) and beat to beat, RR intervals (RRI) files were generated via the data acquisition system (BIOPAC Acknowledge 4.2, Santa Barbara, CA) and analyzed using Nevrokard BRS software (Medistar, Ljubljana, Slovenia) for measures of BRS, HRV and BPV as previously published 19 and described below.…”

Section: Methodsmentioning

confidence: 99%

“… 17 Reduced insomnia symptoms and improved autonomic cardiovascular regulation were observed in a large open label series 18 and a randomized, placebo controlled trial among 107 adults comparing HIRREM to sham auditory stimulation. 19 Among a cohort with military-related post-traumatic stress, reduced self-reported insomnia, post-traumatic stress, depression, anxiety symptoms, and improved autonomic cardiovascular regulation, as well as significant changes in whole brain resting MRI network connectivity were demonstrated. 20 While the HIRREM intervention proved to be safe, effective and well-tolerated in the previous placebo-controlled trial of 107 adults with insomnia, the intervention was based on operator-dependent protocols and required significant participant time (10-20 sessions lasting 90-120 minutes each).…”

Section: Introductionmentioning

confidence: 96%

“… 20 While the HIRREM intervention proved to be safe, effective and well-tolerated in the previous placebo-controlled trial of 107 adults with insomnia, the intervention was based on operator-dependent protocols and required significant participant time (10-20 sessions lasting 90-120 minutes each). 19 …”

Section: Introductionmentioning

confidence: 99%

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

Tegeler

Clary

Shaltout

et al. 2023

Global Advances in Integrative Medicine and Health

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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.

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Section: Discussionmentioning

confidence: 99%

“…However, the magnitude and direction of change in insomnia, sleep quality, and many of the autonomic measures were similar to the benefit demonstrated in our prior larger trial. 19 …”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Tegeler

Clary

Shaltout

et al. 2023

Global Advances in Integrative Medicine and Health

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Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms

Cole,

Tegeler,

Choi

et al. 2023

Ann Clin Transl Neurol

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ObjectiveEffective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham‐controlled trial of Cereset Research™ Standard Operating Procedures (CR‐SOP), a noninvasive, closed‐loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia.MethodsMilitary service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self‐report measures of sleep, mood, and anxiety.ResultsParticipants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P < 0.0001), with gains largely sustained at 3 months (31.2) and 6 months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post‐intervention, 31.5 at 3 months, and 29.4 at 6 months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ‐9 and there was no difference in HRV between groups.InterpretationTen hours of acoustic stimulation while resting in a zero‐gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones.Registration: ClinicalTrials.gov – NCT03649958

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The 2023 nonhormone therapy position statement of The North American Menopause Society

2023

Menopause

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Objective To update the evidence-based Nonhormonal Management of Menopause-Associated Vasomotor Symptoms: 2015 Position Statement of The North American Menopause Society. Methods An advisory panel of clinicians and research experts in women’s health were selected to review and evaluate the literature published since the Nonhormonal Management of Menopause-Associated Vasomotor Symptoms: 2015 Position Statement of The North American Menopause Society. Topics were divided into five sections for ease of review: lifestyle; mind-body techniques; prescription therapies; dietary supplements; and acupuncture, other treatments, and technologies. The panel assessed the most current and available literature to determine whether to recommend or not recommend use based on these levels of evidence: Level I, good and consistent scientific evidence; Level II, limited or inconsistent scientific evidence, and Level III, consensus and expert opinion. Results Evidence-based review of the literature resulted in several nonhormone options for the treatment of vasomotor symptoms. Recommended: Cognitive-behavioral therapy, clinical hypnosis, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors, gabapentin, fezolinetant (Level I); oxybutynin (Levels I-II); weight loss, stellate ganglion block (Levels II-III). Not recommended: Paced respiration (Level I); supplements/herbal remedies (Levels I-II); cooling techniques, avoiding triggers, exercise, yoga, mindfulness-based intervention, relaxation, suvorexant, soy foods and soy extracts, soy metabolite equol, cannabinoids, acupuncture, calibration of neural oscillations (Level II); chiropractic interventions, clonidine; (Levels I-III); dietary modification and pregabalin (Level III). Conclusion Hormone therapy remains the most effective treatment for vasomotor symptoms and should be considered in menopausal women within 10 years of their final menstrual periods. For women who are not good candidates for hormone therapy because of contraindications (eg, estrogen-dependent cancers or cardiovascular disease) or personal preference, it is important for healthcare professionals to be well informed about nonhormone treatment options for reducing vasomotor symptoms that are supported by the evidence.

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High‐resolution, relational, resonance‐based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo‐controlled clinical trial

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 6 publications

References 50 publications

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

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

Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms

The 2023 nonhormone therapy position statement of The North American Menopause Society

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