Evidence map›Paper›PMID 31691105›Full record

Trial reportSleep & breathing = Schlaf & Atmung2020

A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD.

Aaron Holley, David Shaha, Camille Costan-Toth, Jennifer Slowik, Brian D Robertson, Scott G Williams, Seth Terry, Dana Golden, Teotimo Andrada, Sonja Skeete and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02549508 (Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 40% 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.

NCT02549508 nacompletednot on this map

Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD

TypeinterventionalSponsorFisher and Paykel HealthcareRan2015 to 2018Enrolled85ConditionsObstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)ArmsAutoCPAP with SensAwake On, AutoCPAP with SensAwake Off
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Obstructive sleep apnea among survivors of combat-related traumatic injury: a retrospective cohort study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
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

13 authors at 5 institutions in 1 country.

Aaron HolleyWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
David ShahaWomack Army Medical Center, Fort Bragg, NC, USA.
Camille Costan-TothFort Belvoir Community Hospital, Fort Belvoir, VA, USA.
Jennifer SlowikMadigan Army Medical Center, Tacoma, WA, USA.
Brian D RobertsonWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Scott G WilliamsFort Belvoir Community Hospital, Fort Belvoir, VA, USA.
Seth TerryWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Dana GoldenWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Teotimo AndradaWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Sonja SkeeteWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Karen SheikhWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
George ButlerWalter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD, 20889, USA.
Jacob F CollenUniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD, 20814, USA. jacob.collen@usuhs.edu.ORCID http://orcid.org/0000-0002-8064-6391
Walter Reed National Military Medical Center · USAlexander T. Augusta Military Medical Center · USMadigan Army Medical Center · USUniformed Services University of the Health Sciences · USWomack Army Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePositive airway pressure (PAP) adherence is poor in comorbid OSA/PTSD. SensAwake™ (SA) is a wake-sensing PAP algorithm that lowers pressure when wake is detected. We compared auto-PAP (aPAP) with and without SA for comorbid OSA/PTSD.

methodsProspective, randomized crossover study comparing aPAP to aPAP + SA. We enrolled patients with OSA/PTSD who were PAP naïve. Four weeks after randomization, the patients were crossed over to the alternate treatment group, with final follow-up at eight weeks. Sleep questionnaires (ESS, ISI, FSS, and FOSQ-10) were assessed at baseline and follow-up.

resultsWe enrolled 85 patients with OSA/PTSD. aPAP reduced AHI to < 5/h in both groups. Our primary endpoint, average hours of aPAP adherence (total) after 4 weeks, was significantly increased in the SA group in our intention-to-treat (ITT) analysis (ß = 1.13 (95% CI 0.16-2.1); p = 0.02), after adjustment for ESS differences at baseline. After adjustment for ESS, SA (ITT analysis) also showed significant improvement in percentage of nights used for ≥ 4 h (ß = 14.9 (95% CI 1.02-28.9); p = 0.04). There were trends toward an increase in percentage nights used total (ß = 17.4 (95% CI - 0.1 to 34.9); p = 0.05), average hours of aPAP adherence (nights used) (ß = 1.04 (95% CI - 0.07 to 2.1); p = 0.07), and regular use (OR = 7.5 (95% CI 0.9-64.7); p = 0.07) after adjustment for ESS at baseline. After adjustment for ESS and days to cross over, SA by actual assignment did not show any effect on adherence variables. The ESS, ISI, FSS, and FOSQ-10 all showed significant improvements with PAP, but there were no differences in the magnitude of improvement in any score between groups.

conclusionsAdherence to aPAP may be improved with the addition of SA and deserves further study. SA is as effective as standard aPAP for normalizing the AHI and improving sleep-related symptoms. CLINICAL

trial registrationClinicalTrials.gov NCT02549508 https://clinicaltrials.gov/ct2/show/NCT02549508?term=NCT02549508&rank=1 "Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD".

Indexed as

Positive-Pressure RespirationAdultComorbidityCross-Over StudiesFemaleHumansMaleMiddle AgedOutcome Assessment, Health CarePolysomnographyProspective StudiesSeverity of Illness IndexSingle-Blind MethodSleep Apnea, ObstructiveStress Disorders, Post-TraumaticContinuous positive airway pressureCPAPCPAP adherenceCPAP complianceObstructive sleep apneaPost-traumatic stress disorderPTSD

Identifiers

PMID31691105
OpenAlexW2986744524

What OpenQuestion 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 OpenQuestion graph.