Evidence map›Paper›PMID 32940419›Full record

Trial reportBrain and behavior2020

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

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

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brain and behavior, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
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  8. Understanding societal challenges: a NeurotechFrontiers in neuroscience · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Catherine L TegelerDepartment of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.ORCID 0000-0002-2943-6719
Hossam A ShaltoutHypertension and Vascular Research Center, WFSM, Winston-Salem, NC, USA.ORCID 0000-0001-7948-3815
Sung W LeeUniversity of Arizona School of Medicine, Phoenix, AZ, USA.ORCID 0000-0002-7739-2546
Sean L SimpsonDepartment of Biostatistics and Data Sciences, WFSM, Winston-Salem, NC, USA.ORCID 0000-0002-9594-0569
Lee GerdesBrain State Technologies, LLC, Scottsdale, AZ, USA.ORCID 0000-0003-0476-9290
Charles H TegelerDepartment of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.ORCID 0000-0002-8654-8661
Wake Forest University · USHypertension Institute · USScottsdale Research Institute (United States) · USUniversity of Arizona · USWinston-Salem State University · US

Funding

Wake Forest Clinical and Translational Science AwardUL1TR001420 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, FOLEY, KRISTIE L · 2015 to 2023
$32.3M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
Analytical Tools for Complex Brain Networks: Fusing Novel Statistical Methods and Network Science to Understand Brain FunctionR01EB024559 · NIBIB · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI SIMPSON, SEAN L · 2018 to 2021
$1.5M
NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001420NIBIB NIH HHS R01 EB024559The Susanne Marcus Collins Foundation, Inc.
6 · The paper itself

Abstract

introductionEffective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM

methodsOne 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).

resultsOf 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.

conclusionsResults 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.

Indexed as

Sleep Initiation and Maintenance DisordersAdultAutonomic Nervous SystemBaroreflexFemaleHeart RateHumansMiddle AgedQuality of LifeTreatment Outcomeacoustic neuromodulationallostasisautonomicclosed-loop neurotechnologyHIRREMinsomnia

Identifiers

PMID32940419
PMCPMC7667311
OpenAlexW3086511882

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.