title: 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.
abstract: BACKGROUND
  Following 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.
  
  
  METHODS
  Subjects 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01753999, Date: 12 December 2012.
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. indu.ayappa@nyumc.org.
authors.forename: Indu
authors.initials: I
authors.lastname: Ayappa
authors.affiliation: Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 08903, USA. sunderja@rwjms.rutgers.edu.
authors.forename: Jag
authors.initials: J
authors.lastname: Sunderram
authors.affiliation: Environmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. kgb3@rwjms.rutgers.edu.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Black
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. Akosua.Twumasi@nyumc.org.
authors.forename: Akosua
authors.initials: A
authors.lastname: Twumasi
authors.affiliation: Environmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. udasinir@rwjms.rutgers.edu.
authors.forename: Iris
authors.initials: I
authors.lastname: Udasin
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. Denise.Harrison@nyumc.org.
authors.forename: Denise
authors.initials: D
authors.lastname: Harrison
authors.affiliation: Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 08903, USA. carson@rwjms.rutgers.edu.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Carson
authors.affiliation: Environmental and Occupational Health Sciences Institute, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. sl1020@sph.rutgers.edu.|School of Public Health, Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA. sl1020@sph.rutgers.edu.
authors.forename: Shou-En
authors.initials: SE
authors.lastname: Lu
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, New York University School of Medicine, New York, NY, USA. David.Rapoport@nyumc.org.
authors.forename: David M
authors.initials: DM
authors.lastname: Rapoport
mesh_terms: D000403:Airway Resistance; D002985:Clinical Protocols; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000379:methods*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D060731:Emergency Responders; D006801:Humans; D009296:Nasal Cavity / Q000503:physiopathology*; D015508:Nasal Obstruction / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology*; D009515:New Jersey; D009519:New York City; D016272:Occupational Health; D010349:Patient Compliance; D012107:Research Design; D047851:September 11 Terrorist Attacks; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D012913:Snoring / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome