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Nasal dilator strip therapy for chronic sleep-maintenance insomnia and symptoms of sleep-disordered breathing: a randomized controlled trial

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Abstract

To test the impact of nasal dilator strips (NDSs) on insomnia severity, sleep-disordered breathing (SDB) symptoms, sleep quality, and quality of life. Randomized, controlled trial of 4 weeks' duration. Community sample of nonobese, adults with a primary sleep complaint of chronic sleep-maintenance insomnia and mild to moderate SDB symptoms (treatment, n=42; control, n=38). Primary outcomes were four validated scales: Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Questionnaire (FOSQ), and Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). Secondary outcomes were sleep indices, nonrestorative sleep ratings, and SDB symptoms, assessed retrospectively and prospectively. Both groups received nonspecific education about sleep disorders. Treatment group also received a brief SDB education and nasal strip instructions. At 4 weeks' follow-up, the treatment group demonstrated significant (p=.0001), large improvements in ISI and PSQI (mean Cohen's d=1.18) and significant (p<.02), medium-sized improvements in FOSQ and QLESQ (mean d=0.51) compared to small, nonsignificant changes in control group (Cohen's d range=0.36–0.09). Treatment group change scores among all four primary variables were significantly correlated (mean r=0.50, p=0.01). Secondary prospective and retrospective outcomes showed medium to large improvements in treatment compared to controls for sleep indices (mean d=0.52 vs 0.28), nonrestorative sleep ratings (mean d=0.69 vs 0.11), and sleep breathing symptoms (mean d=0.47 vs 0.09). Significance was obtained for prospective sleep indices (p=0.01), retrospective, and prospective nonrestorative sleep ratings (p=0.003, <0.05), and retrospective sleep breathing symptoms (p=0.03). SDB education and NDSs demonstrated therapeutic efficacy in a select sample of insomnia patients with SDB symptoms. Replication of results requires placebo controls and objectively confirmed SDB cases.

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References

  1. Guilleminault C, Eldridge FL, Dement WC (1973) Insomnia with sleep apnea: a new syndrome. Science 181(102):856–858

    Article  PubMed  CAS  Google Scholar 

  2. Krakow B, Melendrez D, Ferreira E et al (2001) Prevalence of insomnia symptoms in patients with sleep-disordered breathing. Chest 120(6):1923–1929

    Article  PubMed  CAS  Google Scholar 

  3. Smith S, Sullivan K, Hopkins W et al (2004) Frequency of insomnia report in patients with obstructive sleep apnoea hypopnea syndrome (OSAHS). Sleep Med 5(5):449–456

    Article  PubMed  Google Scholar 

  4. Krakow B (2004) An emerging interdisciplinary sleep medicine perspective on the high prevalence of co-morbid sleep-disordered breathing and insomnia. Sleep Med 5(5):431–433

    Article  PubMed  Google Scholar 

  5. Krakow B, Melendrez D, Pedersen B et al (2001) Complex insomnia: insomnia and sleep-disordered breathing in a consecutive series of crime victims with nightmares and PTSD. Biol Psychiatry 49(11):948–953

    Article  PubMed  CAS  Google Scholar 

  6. Krakow B, Melendrez D, Johnston L et al (2002) Sleep-disordered breathing, psychiatric distress, and quality of life impairment in sexual assault survivors. J Nerv Ment Dis 190(7):442–452

    Article  PubMed  Google Scholar 

  7. Guilleminault C, Palombini L, Poyares D et al (2002) Chronic insomnia, postmenopausal women, and sleep disordered breathing: part 1. Frequency of sleep disordered breathing in a cohort. J Psychosom Res 53(1):611–615

    Article  PubMed  Google Scholar 

  8. Gold AR, Dipalo F, Gold MS et al (2003) The symptoms and signs of upper airway resistance syndrome: a link to the functional somatic syndromes. Chest 123(1):87–95

    Article  PubMed  Google Scholar 

  9. Krakow B, Haynes PL, Warner TD et al (2004) Nightmares, insomnia, and sleep-disordered breathing in fire evacuees seeking treatment for posttraumatic sleep disturbance. J Trauma Stress 17:257–268

    Article  PubMed  Google Scholar 

  10. Gold AR, Dipalo F, Gold MS et al (2004) Inspiratory airflow dynamics during sleep in women with fibromyalgia. Sleep 27:459–466

    PubMed  Google Scholar 

  11. Chung KF, Krakow B, Melendrez DC et al (2003) Relationships between insomnia and sleep-disordered breathing. Chest 123:310–313

    Article  PubMed  Google Scholar 

  12. Guilleminault C, Stoohs R, Kim YD et al (1995) Upper airway sleep-disordered breathing in women. Ann Intern Med 122(7):493–501

    PubMed  CAS  Google Scholar 

  13. Lavie P, Gertner R, Zomer J et al (1981) Breathing disorders in sleep associated with “microarousals” in patients with allergic rhinitis. Acta Otolaryngol 92(5–6):529–533

    Article  PubMed  CAS  Google Scholar 

  14. Staevska MT, Mandajieva MA, Dimitrov VD (2004) Rhinitis and sleep apnea. Curr Allergy Asthma Rep 4(3):193–199

    Article  PubMed  Google Scholar 

  15. Guilleminault C, Palombini L, Poyares D et al (2002) Chronic insomnia, premenopausal women and sleep disordered breathing: part 2. Comparison of nondrug treatment trials in normal breathing and UARS post menopausal women complaining of chronic insomnia. J Psychosom Res 53(1):617–623

    Article  PubMed  Google Scholar 

  16. Ferguson BJ (2004) Influences of allergic rhinitis on sleep. Otolaryngol Head Neck Surg 130:617–629

    Article  PubMed  Google Scholar 

  17. Rappai M, Collop N, Kemp S et al (2003) The nose and sleep-disordered breathing: what we know and what we do not know. Chest 124(6):2309–2323

    Article  PubMed  Google Scholar 

  18. Krakow B, Melendrez D, Sisley B et al (2004) Nasal dilator strip therapy for chronic sleep maintenance insomnia: a case series. Sleep Breath 8(3):133–140

    Article  PubMed  Google Scholar 

  19. Scharf MB, Brannen DE, McDannold M (1994) A subjective evaluation of a nasal dilator on sleep and snoring. Ear Nose Throat J 73(6):395–401

    PubMed  CAS  Google Scholar 

  20. Turnbull GL, Rundell OH, Rayburn WF et al (1996) Managing pregnancy-related nocturnal nasal congestion. The external nasal dilator. J Reprod Med 41(12):897–902

    PubMed  CAS  Google Scholar 

  21. Scharf MB, Berkowitz DV, McDannold MD et al (1996) Effects of an external nasal dilator on sleep and breathing patterns in newborn infants with and without congestion. J Pediatr 129(6):804–808

    Article  PubMed  CAS  Google Scholar 

  22. Ulfberg J, Fenton G (1997) Effect of breathe right nasal strip on snoring. Rhinology 35(2):50–52

    PubMed  CAS  Google Scholar 

  23. Liistro G, Rombaux P, Dury M et al (1998) Effects of breathe right on snoring: a polysomnographic study. Respir Med 92(8):1076–1078

    Article  PubMed  CAS  Google Scholar 

  24. Todorova A, Schellenberg R, Hofmann HC et al (1998) Effect of the external nasal dilator breathe right on snoring. Eur J Med Res 3(8):367–379

    PubMed  CAS  Google Scholar 

  25. Redline S, Adams N, Strauss ME et al (1998) Improvement of mild sleep-disordered breathing with CPAP compared with conservative therapy. Am J Respir Crit Care Med 157(3 Pt 1):858–865

    PubMed  CAS  Google Scholar 

  26. Di Somma EM, West SN, Wheatley JR et al (1999) Nasal dilator strips increase maximum inspiratory flow via nasal wall stabilization. Laryngoscope 109:780–784

    Article  PubMed  Google Scholar 

  27. Bahammam AS, Tate R, Manfreda J et al (1999) Upper airway resistance syndrome: effect of nasal dilation, sleep stage, and sleep position. Sleep 22(5):592–598

    PubMed  CAS  Google Scholar 

  28. Gosepath J, Amedee RG, Romantschuck S et al (1999) Breathe right nasal strips and the respiratory disturbance index in sleep related breathing disorders. Am J Rhinol 13(5):385–389

    Article  PubMed  CAS  Google Scholar 

  29. Djupesland PG, Skatvedt O, Borgersen AK (2001) Dichotomous physiological effects of nocturnal external nasal dilation in heavy snorers: the answer to a rhinologic controversy? Am J Rhinol 15(2):95–103

    Article  PubMed  CAS  Google Scholar 

  30. American Academy of Sleep Medicine (1997) The international classification of sleep disorders. Allen, Lawrence, pp 52–58

    Google Scholar 

  31. Umlauf MG, Chasens ER (2003) Sleep disordered breathing and nocturnal polyuria: nocturia and enuresis. Sleep Med Rev 7(5):403–411

    Article  PubMed  Google Scholar 

  32. Loh NK, Dinner DS, Foldvary N et al (1999) Do patients with obstructive sleep apnea wake up with headaches? Arch Intern Med 159(15):1765–1768

    Article  PubMed  CAS  Google Scholar 

  33. Sateia MJ, Doghramji K, Hauri PJ et al (2000) Evaluation of chronic insomnia. An American Academy of Sleep Medicine review. Sleep 23(2):243–308

    PubMed  CAS  Google Scholar 

  34. American Academy of Sleep Medicine (1999) Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The report of an American Academy of Sleep Medicine Task Force. Sleep 22(5):667–689

    Google Scholar 

  35. Harvey AG, Tang NK (2003) Cognitive behaviour therapy for primary insomnia: can we rest yet? Sleep Med Rev 7(3):237–262

    Article  PubMed  Google Scholar 

  36. Bastien CH, Vallieres A, Morin CM (2001) Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2(4):297–307

    Article  PubMed  Google Scholar 

  37. Buysse DJ, Reynolds CF III, Monk TH et al (1989) The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 28(2):193–213

    Article  PubMed  CAS  Google Scholar 

  38. Weaver TE, Laizner AM, Evans LK et al (1997) An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep 20(10):835–843

    PubMed  CAS  Google Scholar 

  39. Endicott J, Nee J, Harrison W et al (1993) Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull 29(2):321–326

    PubMed  CAS  Google Scholar 

  40. Goldberg AN, Schwab RJ (1998) Identifying the patient with sleep apnea: upper airway assessment and physical examination. Otolaryngol Clin North Am 31(6):919–930

    Article  PubMed  CAS  Google Scholar 

  41. Liistro G, Rombaux P, Belge C et al (2003) High Mallampati score and nasal obstruction are associated risk factors for obstructive sleep apnoea. Eur Respir J 21(2):248–252

    Article  PubMed  CAS  Google Scholar 

  42. Viviano JS (2002) Acoustic reflection: review and clinical applications for sleep-disordered breathing. Sleep Breath 6(3):129–149

    Article  PubMed  Google Scholar 

  43. Cohen J (2005) Statistical power analysis for the behavioral sciences. Erlbaum, Hillsdale

    Google Scholar 

  44. Krakow B, Melendrez D, Lee SA et al (2004) Refractory insomnia and sleep-disordered breathing: a pilot study. Sleep Breath 8(1):15–29

    Article  PubMed  Google Scholar 

  45. Henke KG, Grady JJ, Kuna ST (2001) Effect of nasal continuous positive airway pressure on neuropsychological function in sleep apnea–hypopnea syndrome. A randomized, placebo-controlled trial. Am J Respir Crit Care Med 163(4):911–917

    PubMed  CAS  Google Scholar 

  46. Portugal LG, Mehta RH, Smith BE et al (1997) Objective assessment of the breathe-right device during exercise in adult males. Am J Rhinol 11(5):393–397

    Article  PubMed  CAS  Google Scholar 

  47. Ho WK, Wei WI, Yuen AP et al (2000) Effect of the external nasal dilator on nasal minimal cross-sectional area in orientals as assessed by acoustic rhinometry. J Otolaryngol 29(6):367–370

    PubMed  CAS  Google Scholar 

  48. Sullivan CE, Issa FG, Berthon-Jones M et al (1981) Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet 1(8225):862–865

    Article  PubMed  CAS  Google Scholar 

  49. Schmidt-Nowara W (1999) Recent developments in oral appliance therapy of sleep disordered breathing. Sleep Breath 3(3):103–106

    Article  PubMed  Google Scholar 

  50. Gotsopoulos H, Chen C, Qian J et al (2002) Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial. Am J Respir Crit Care Med 166(5):743–748

    Article  PubMed  Google Scholar 

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Acknowledgement

Support for this study was provided by an unrestricted grant from CNS., Inc. (Minneapolis, MN), the manufacturer of Breathe Right® nasal strips.

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Authors and Affiliations

  1. Sleep and Human Health Institute, Suite 380, 6739 Academy NE, Albuquerque, NM, 87109, USA

    Barry Krakow, Dominic Melendrez, Brandy Sisley, Jessica Krakow, Lisa Leahigh & Sam Lee

  2. Maimonides Sleep Arts and Sciences, Ltd., Albuquerque, NM, USA

    Barry Krakow, Dominic Melendrez, Brandy Sisley & Jessica Krakow

  3. Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM, USA

    Barry Krakow

  4. Department of Emergency Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA

    Barry Krakow

  5. Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA

    Teddy D. Warner

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  1. Barry Krakow
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  2. Dominic Melendrez
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  5. Jessica Krakow
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  7. Sam Lee
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Correspondence to Barry Krakow.

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Krakow, B., Melendrez, D., Sisley, B. et al. Nasal dilator strip therapy for chronic sleep-maintenance insomnia and symptoms of sleep-disordered breathing: a randomized controlled trial. Sleep Breath 10, 16–28 (2006). https://doi.org/10.1007/s11325-005-0037-7

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