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

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.

Study design: 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.

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 registration: ClinicalTrials.gov Identifier: NCT01753999, Date: 12 December 2012.

Figures

Fig. 1
Fig. 1
Protocol flow chart. Simplified illustration of the protocol for all participants. CPAP, continuous positive airway pressure; CPAPFlex, continuous positive airway pressure with reduced pressure during expiration OSA, obstructive sleep apnea

References

    1. Herbert R, Moline J, Skloot G, Metzger K, Baron S, Luft B, et al. The World Trade Center disaster and the health of workers: five-year assessment of a unique medical screening program. Environ Health Perspect. 2006;114(12):1853–8.
    1. Moline JM, Herbert R, Levin S, Stein D, Luft BJ, Udasin IG, et al. WTC medical monitoring and treatment program: comprehensive health care response in aftermath of disaster. Mt Sinai J Med. 2008;75(2):67–75. doi: 10.1002/msj.20022.
    1. Chen LC, Thurston G. World Trade Center cough. Lancet. 2002;360(Suppl):s37–8. doi: 10.1016/S0140-6736(02)11814-9.
    1. McGee JK, Chen LC, Cohen MD, Chee GR, Prophete CM, Haykal-Coates N, et al. Chemical analysis of World Trade Center fine particulate matter for use in toxicologic assessment. Environ Health Perspect. 2003;111(7):972–80. doi: 10.1289/ehp.5930.
    1. Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993;328(17):1230–5. doi: 10.1056/NEJM199304293281704.
    1. Young T. Rationale, design and findings from the Wisconsin Sleep Cohort Study: toward understanding the total societal burden of sleep disordered breathing. Sleep Med Clin. 2009;4(1):37–46. doi: 10.1016/j.jsmc.2008.11.003.
    1. Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, O'Connor GT, et al. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med. 2009;6(8):e1000132. doi: 10.1371/journal.pmed.1000132.
    1. Young T, Finn L, Kim H. Nasal obstruction as a risk factor for sleep-disordered breathing. The University of Wisconsin Sleep and Respiratory Research Group. J Allergy Clin Immunol. 1997;99(2):S757–62. doi: 10.1016/S0091-6749(97)70124-6.
    1. Sanders MH, Montserrat JM, Farre R, Givelber RJ. Positive pressure therapy: a perspective on evidence-based outcomes and methods of application. Proc Am Thorac Soc. 2008;5(2):161–72. doi: 10.1513/pats.200709-150MG.
    1. McArdle N, Douglas NJ. Effect of continuous positive airway pressure on sleep architecture in the sleep apnea-hypopnea syndrome: a randomized controlled trial. Am J Respir Crit Care Med. 2001;164(8 Pt 1):1459–63. doi: 10.1164/ajrccm.164.8.2008146.
    1. Pepperell JC, Ramdassingh-Dow S, Crosthwaite N, Mullins R, Jenkinson C, Stradling JR, et al. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Lancet. 2002;359(9302):204–10. doi: 10.1016/S0140-6736(02)07445-7.
    1. Patel SR, White DP, Malhotra A, Stanchina ML, Ayas NT. Continuous positive airway pressure therapy for treating sleepiness in a diverse population with obstructive sleep apnea: results of a meta-analysis. Arch Intern Med. 2003;163(5):565–71. doi: 10.1001/archinte.163.5.565.
    1. George CF. Reduction in motor vehicle collisions following treatment of sleep apnoea with nasal CPAP. Thorax. 2001;56(7):508–12. doi: 10.1136/thorax.56.7.508.
    1. Fava C, Dorigoni S, Dalle Vedove F, Danese E, Montagnana M, Guidi GC, et al. Effect of CPAP on blood pressure in patients with OSA/hypopnea a systematic review and meta-analysis. Chest. 2014;145(4):762–71. doi: 10.1378/chest.13-1115.
    1. Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008;5(2):173–8. doi: 10.1513/pats.200708-119MG.
    1. Sugiura T, Noda A, Nakata S, Yasuda Y, Soga T, Miyata S, et al. Influence of nasal resistance on initial acceptance of continuous positive airway pressure in treatment for obstructive sleep apnea syndrome. Respiration. 2007;74(1):56–60. doi: 10.1159/000089836.
    1. Engleman HM, Wild MR. Improving CPAP use by patients with the sleep apnoea/hypopnoea syndrome (SAHS) Sleep Med Rev. 2003;7(1):81–99. doi: 10.1053/smrv.2001.0197.
    1. Virkkula P, Maasilta P, Hytonen M, Salmi T, Malmberg H. Nasal obstruction and sleep-disordered breathing: the effect of supine body position on nasal measurements in snorers. Acta Otolaryngol. 2003;123(5):648–54. doi: 10.1080/00016480310001493.
    1. Nakata S, Noda A, Yagi H, Yanagi E, Mimura T, Okada T, et al. Nasal resistance for determinant factor of nasal surgery in CPAP failure patients with obstructive sleep apnea syndrome. Rhinology. 2005;43(4):296–9.
    1. Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005;127(6):2085–93. doi: 10.1378/chest.127.6.2085.
    1. Pepin JL, Muir JF, Gentina T, Dauvilliers Y, Tamisier R, Sapene M, et al. Pressure reduction during exhalation in sleep apnea patients treated by continuous positive airway pressure. Chest. 2009;136(2):490–7.
    1. Vogt K, Jalowayski AA, Althaus W, Cao C, Han D, Hasse W, et al. 4-Phase-Rhinomanometry (4PR) – basics and practice. Rhinol Suppl. 2010;2010(21):1–50.
    1. Redline S, Sanders M. Hypopnea, a floating metric: implications for prevalence, morbidity estimates, and case finding. Sleep. 1997;20(12):1209–17.
    1. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med. 2007;3(2):169–200.
    1. Ayappa I, Norman RG, Seelall V, Rapoport DM. Validation of a self-applied unattended monitor for sleep disordered breathing. J Clin Sleep Med. 2008;4(1):26–37.
    1. Ayappa I, Norman RG, Suryadevara M, Rapoport DM. Comparison of limited monitoring using a nasal-cannula flow signal to full polysomnography in sleep-disordered breathing. Sleep. 2004;27(6):1171–9.
    1. Masdeu MJ, Ayappa I, Hwang D, Mooney AM, Rapoport DM. Impact of clinical assessment on use of data from unattended limited monitoring as opposed to full-in lab PSG in sleep disordered breathing. J Clin Sleep Med. 2010;6(1):51–8.
    1. Morgenthaler TI, Aurora RN, Brown T, Zak R, Alessi C, Boehlecke B, et al. Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007. An American Academy of Sleep Medicine report. Sleep. 2008;31(1):141–7.
    1. Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, et al. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011;34(8):1083–92.
    1. Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205–22. doi: 10.1207/s15402010bsm0204_3.
    1. Budhiraja R, Parthasarathy S, Drake CL, Roth T, Sharief I, Budhiraja P, et al. Early CPAP use identifies subsequent adherence to CPAP therapy. Sleep. 2007;30(3):320–4.
    1. Chai-Coetzer CL, Luo YM, Antic NA, Zhang XL, Chen BY, He QY, et al. Predictors of long-term adherence to continuous positive airway pressure therapy in patients with obstructive sleep apnea and cardiovascular disease in the SAVE study. Sleep. 2013;36(12):1929–37.
    1. Somiah M, Taxin Z, Keating J, Mooney AM, Norman RG, Rapoport DM, et al. Sleep quality, short-term and long-term CPAP adherence. J Clin Sleep Med. 2012 Oct 15;8(5):489-500.
    1. Rosner B. Fundamentals of biostatistics. 7. Boston: Brooks/Cole, Cengage Learning; 2011.
    1. Lachenbruch PA. Comparisons of two-part models with competitors. Stat Med. 2001;20(8):1215–34. doi: 10.1002/sim.790.
    1. Lu SE, Lin Y, Shih WC. Analyzing excessive no changes in clinical trials with clustered data. Biometrics. 2004;60(1):257–67. doi: 10.1111/j.0006-341X.2004.00155.x.
    1. Berry RB, Hill G, Thompson L, McLaurin V. Portable monitoring and autotitration versus polysomnography for the diagnosis and treatment of sleep apnea. Sleep. 2008;31(10):1423–31.
    1. Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, et al. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011;183(9):1238–44. doi: 10.1164/rccm.201011-1770OC.
    1. Mulgrew AT, Fox N, Ayas NT, Ryan CF. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007;146(3):157–66. doi: 10.7326/0003-4819-146-3-200702060-00004.

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