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

Sleep and Breathing volume 10, pages 16–28 (2006)Cite this article

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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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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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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