Evidence map›Paper›PMID 33295277›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2021

Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial.

Jason L Yu, Magdy Younes

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01161420 (Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT01161420 phase3completednot on this map

Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

TypeinterventionalSponsorInspire Medical Systems, Inc.Ran2010 to 2017Enrolled929ConditionsObstructive Sleep ApneaArmsInspire Upper Airway Stimulation System
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Early objective adherence to hypoglossal nerve stimulation therapy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  5. Article
  6. Review
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

2 authors.

Jason L YuDepartment of Otorhinolaryngology-Head and Neck Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Magdy YounesSleep Disorders Centre, Winnipeg, Manitoba, Canada.

Funding

TRAINING PROGRAM/RESPIRATORY NEUROBIOLOGY AND SLEEPT32HL007713 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI PACK, ALLAN I · 1992 to 2022
$11.9M
NHLBI NIH HHS T32 HL007713
6 · The paper itself

Abstract

STUDY

objectivesUpper airway stimulation (UAS) is an innovative surgical treatment for obstructive sleep apnea; however, the treatment failure rate is approximately 22%. Easy arousability may limit the tolerability of stimulation and, by extension, its effectiveness. The odds ratio product (ORP) is a continuous electroencephalographic metric of arousal propensity (range: 0 [deep sleep] to 2.5 [full wakefulness]), and its rate of decline after arousal (ORP-9) is a risk factor for susceptibility to arousal in the presence of frequent arousal stimuli. We hypothesized that individuals with deeper sleep (low average ORP and low ORP-9) are more likely to respond to UAS.

methodsORP and ORP-9 were calculated from 126 baseline polysomnograms of participants in the STAR Trial. These values were compared between responders and nonresponders. Adjusted linear modeling was performed to determine the association between ORP-derived variables and treatment response.

resultsNo differences were found between responders and nonresponders in unadjusted comparisons of ORP-derived variables. On linear regression modeling, significant correlation was found between non-rapid eye movement ORP and reduction in apnea-hypopnea index (P = .004).

conclusionsNo significant difference in ORP was noted between responders and nonresponders to UAS therapy; however, contrary to our initial hypothesis, linear regression modeling trended toward a positive relationship between ORP and UAS response, suggesting that those who have lighter sleep are more likely to respond to therapy; however, these results are only exploratory, and future larger prospective studies are needed to confirm this relationship. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: STAR Trial; Identifier: NCT01161420.

Indexed as

Electric Stimulation TherapySleep Apnea, ObstructiveHumansPolysomnographyProspective StudiesSleepWakefulnessarousalhypoglossal nerve stimulationORPOSAUAS

Identifiers

PMID33295277
PMCPMC8020691

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.