Evidence map›Paper›PMID 26357928›Full record

Trial reportTrials2015

A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial.

Indu Ayappa, Jag Sunderram, Kathleen Black, Akosua Twumasi, Iris Udasin, Denise Harrison, Jeffrey L Carson, Shou-En Lu, David M Rapoport

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01753999 (Obstructive Sleep Apnea in WTC Responders), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 43% 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.

NCT01753999 nacompletednot on this map

Obstructive Sleep Apnea in WTC Responders: Role of Nasal Pathology

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2012 to 2017Enrolled317ConditionsObstructive Sleep ApneaArmsStandard CPAP, CPAP - Flex
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Nasal resistance and inflammation: mechanisms for obstructive sleep apnea from chronic rhinosinusitis.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Article
  5. 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

9 authors at 3 institutions in 1 country.

Indu AyappaDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. indu.ayappa@nyumc.org.
Jag SunderramDepartment of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 08903, USA. sunderja@rwjms.rutgers.edu.
Kathleen BlackEnvironmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. kgb3@rwjms.rutgers.edu.
Akosua TwumasiDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. Akosua.Twumasi@nyumc.org.
Iris UdasinEnvironmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. udasinir@rwjms.rutgers.edu.
Denise HarrisonDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. Denise.Harrison@nyumc.org.
Jeffrey L CarsonDepartment of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 08903, USA. carson@rwjms.rutgers.edu.
Shou-En LuEnvironmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. sl1020@sph.rutgers.edu.
David M RapoportDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. David.Rapoport@nyumc.org.
New York University · USRutgers, The State University of New Jersey · USJohnson University · US

Funding

Project-005UL1TR001445 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BREDELLA, MIRIAM ANTOINETTE, HOCHMAN, JUDITH S · 2015 to 2025
$103.5M
Translational Research Support CoreP30ES005022 · NIEHS · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Jose Guillermo Cedeno Laurent · 1988 to 2026
$47.4M
Institutional Clinical and Translational Science AwardUL1TR000038 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI CRONSTEIN, BRUCE NEIL · 2012 to 2014
$16.8M
Obstructive Sleep Apnea in WTC Responders: Role of Nasal PathologyU01OH010415 · OH · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI AYAPPA, INDU A, SUNDERRAM, JAG · 2012 to 2015
$4.0M
Mentoring Research in the Physiology of Sleep Disordered BreathingK24HL109156 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI AYAPPA, INDU A · 2013 to 2023
$1.0M
NCATS NIH HHS UL1 TR000038NCATS NIH HHS UL1 TR001445NHLBI NIH HHS K24 HL109156NIEHS NIH HHS P30 ES005022NIOSH CDC HHS NIOSH/CDC U01OH01415NIOSH CDC HHS U01 OH010415PHS HHS 109156PHS HHS P30ESO05022
6 · The paper itself

Abstract

backgroundFollowing the World Trade Center disaster, a large number of individuals involved in rescue and recovery activity were exposed to significant amounts of dust, and reported symptoms of chronic nasal and sinus inflammation. An unusually high prevalence of obstructive sleep apnea (OSA) has also been observed in this World Trade Center Responder population. This project aims to examine the relationship between nasal pathology and OSA. Our hypothesis is that increased nasal resistance due to nasal inflammation predisposes to OSA in this population. Continuous Positive Airway Pressure (CPAP) is the standard therapy for OSA but despite its efficacy has poor adherence. Subjects with high nasal resistance may have greater difficulty in tolerating this therapy than those who do not have high nasal resistance. Reduction of excess expiratory positive pressure by the modality known as Cflex(™) during Continuous Positive Airway Pressure therapy (CPAP(Flex)) has been suggested to improve comfort without compromising efficacy. We will compare CPAP to CPAP(Flex) in subjects with OSA. STUDY

designSubjects with new onset habitual snoring will be screened for OSA using home sleep studies and rhinomanometry will be used to determine nasal resistance. In 400 subjects with OSA we will perform a randomized double blind cross-over study comparing CPAP to CPAP(flex), and relate nasal resistance to adherence to CPAP therapy. DISCUSSION: This is the first multicenter trial designed to test the hypothesis that adherence to CPAP therapy relates to nasal resistance and CPAP(Flex) will improve adherence to CPAP in those subjects with high nasal resistance. We anticipate the following results from this trial: 1. Increased nasal resistance is associated with decreased adherence to CPAP therapy. 2. Use of CPAP(Flex) improves adherence with CPAP therapy in subjects with high nasal resistance, but not in those with low nasal resistance. 3. The benefit of CPAP(Flex) on adherence is greatest when offered at CPAP therapy initiation rather than as a "rescue" therapy in subjects with high nasal resistance.

trial registrationClinicalTrials.gov Identifier: NCT01753999, Date: 12 December 2012.

Indexed as

Emergency RespondersOccupational HealthSeptember 11 Terrorist AttacksAirway ResistanceClinical ProtocolsContinuous Positive Airway PressureCross-Over StudiesDouble-Blind MethodHumansNasal CavityNasal ObstructionNew JerseyNew York CityPatient ComplianceResearch DesignSleep Apnea, Obstructive

Identifiers

PMID26357928
PMCPMC4566493
OpenAlexW1897524850

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.