Evidence map›Paper›PMID 37284759›Full record

Trial reportSleep2023

Transvenous phrenic nerve stimulation is associated with normalization of nocturnal heart rate perturbations in patients with central sleep apnea.

Mathias Baumert, Dominik Linz, Scott McKane, Sarah Immanuel

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01816776 (A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT01816776 nacompletednot on this map

A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea

TypeinterventionalSponsorRespicardia, Inc.Ran2013 to 2017Enrolled151ConditionsSleep Apnea, Central, Sleep Disordered Breathing, Heart FailureArmsTreatment Group (transvenous stimulation of the phrenic nerve), Control Group (Optimal Medical Therapy)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 4 countries.

Mathias BaumertDiscipline of Biomedical Engineering, School of Electrical and Mechanical Engineering, The University of Adelaide, Adelaide, Australia.ORCID 0000-0003-2984-2167
Dominik LinzDepartment of Cardiology, Maastricht University Medical Centre and Cardiovascular Research Institute, Maastricht, The Netherlands.ORCID 0000-0003-4893-0824
Scott McKaneZOLL Respicardia, Inc. Minnetonka, MN, USA.ORCID 0000-0002-2886-6864
Sarah ImmanuelDiscipline of Biomedical Engineering, School of Electrical and Mechanical Engineering, The University of Adelaide, Adelaide, Australia.
Coskata (United States) · USThe University of Adelaide · AUTorrens University Australia · AUUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo determine the effect of transvenous phrenic nerve stimulation (TPNS) on nocturnal heart rate perturbations in patients with CSA.

methodsIn this ancillary study of the remedē System Pivotal Trial, we analyzed electrocardiograms from baseline and follow-up overnight polysomnograms (PSG) in 48 CSA patients in sinus rhythm with implanted TPNS randomized to stimulation (treatment group; TPNS on) or no stimulation (control group; TPNS off). We quantified heart rate variability in the time and frequency domain. Mean change from baseline and standard error is provided.

resultsTPNS titrated to reduce respiratory events is associated with reduced cyclical heart rate variations in the very low-frequency domain across REM (VLFI: 4.12 ± 0.79% vs. 6.87 ± 0.82%, p = 0.02) and NREM sleep (VLFI: 5.05 ± 0.68% vs. 6.74 ± 0.70%, p = 0.08) compared to the control group. Further, low-frequency oscillations were reduced in the treatment arm in REM (LFn: 0.67 ± 0.03 n.u. vs. 0.77 ± 0.03 n.u., p = 0.02) and NREM sleep (LFn: 0.70 ± 0.02 n.u. vs. 0.76 ± 0.02 n.u., p = 0.03).

conclusionIn adult patients with moderate to severe central sleep apnea, transvenous phrenic nerve stimulation reduces respiratory events and is associated with the normalization of nocturnal heart rate perturbations. Long-term follow-up studies could establish whether the reduction in heart rate perturbation by TPNS also translates into cardiovascular mortality reduction. CLINICAL TRIAL: A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea, ClinicalTrials.gov, NCT01816776.

Indexed as

Electric Stimulation TherapySleep Apnea, CentralAdultHeart RateHumansPhrenic NerveProspective StudiesQuality of LifeTreatment Outcomecentral sleep apneaheart rate variabilitytransvenous phrenic nerve stimulation

Identifiers

PMID37284759
PMCPMC10485567
OpenAlexW4379600425

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.