A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing


Tongue retaining devices (TRDs) are one type of oral appliance used to treat sleep disordered breathing. Previous studies have evaluated customized TRDs in comparison to mandibular repositioner appliances. The purpose of this study was to evaluate a noncustomized TRD compared to a control device. A randomized, controlled, crossover design was utilized. The primary outcome was the difference in reduction of the respiratory disturbance index (RDI) between the active suction device (S) and the control, nonsuction device (NS). Secondary outcomes included snoring index, Epworth Sleepiness Scale as well as patient and partner quality-of-life index. Crossover analysis found that only the S device significantly reduced the RDI by 4.9 (95% confidence interval 0.85–8.9) events more than the NS device. This represented a reduction in mean RDI from baseline of 15.5 (±17.6) to 8.9 (±7.6) with the S device. Significant reduction in snoring index was also only found with the S device (214.7–132.9 per hour). Fifty-four percent of subjects indicated they would continue to use only the S device. The S device, with suction, showed better objective and subjective outcomes. Future studies are needed to evaluate these types of devices in larger populations with a wide range of disease severity.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3


  1. 1.

    Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S (1993) The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 328:1230–1235

    PubMed  Article  CAS  Google Scholar 

  2. 2.

    Gislason T, Janson C, Tomasson K (1995) Epidemiological aspects of snoring and hypertension. J Sleep Res 4:145–149

    PubMed  Article  Google Scholar 

  3. 3.

    Olson LG, King MT, Hensley MJ, Saunders NA (1995) A community study of snoring and sleep-disordered breathing. Prevalence. Am J Respir Crit Care Med 152:711–716

    PubMed  CAS  Google Scholar 

  4. 4.

    Whittle AT, Finch SP, Mortimore IL, MacKay TW, Douglas NJ (1997) Use of home sleep studies for diagnosis of the sleep apnoea/hypopnoea syndrome. Thorax 52:1068–1073

    PubMed  CAS  Article  Google Scholar 

  5. 5.

    Young T, Evans L, Finn L, Palta M (1997) Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep 20:705–706

    PubMed  CAS  Google Scholar 

  6. 6.

    Kapur V, Strohl KP, Redline S, Iber C, O'Connor G, Nieto J (2002) Underdiagnosis of sleep apnea syndrome in U.S. communities. Sleep Breath 6:54

    Article  Google Scholar 

  7. 7.

    White J, Cates C, Wright J (2003) Continuous positive airways pressure for obstructive sleep apnoea. Cochrane Database Syst Rev 3:CD001106

    Google Scholar 

  8. 8.

    Chervin RD, Theut S, Bassetti C, Aldrich MS (1997) Compliance with nasal CPAP can be improved by simple interventions. Sleep 20:284–289

    PubMed  CAS  Google Scholar 

  9. 9.

    Pepin JL, Krieger J, Rodenstein D, Cornette A, Sforza E, Delguste P, Deschaux C, Grillier V, Levy P (1999) Effective compliance during the first 3 months of continuous positive airway pressure. A European prospective study of 121 patients. Am J Respir Crit Care Med 160:1124–1129

    PubMed  CAS  Google Scholar 

  10. 10.

    Mehta A, Qian J, Petocz P, Darendeliler MA, Cistulli PA (2001) A randomized, controlled study of a mandibular advancement splint for obstructive sleep apnea. Am J Respir Crit Care Med 163:1457–1461

    PubMed  CAS  Google Scholar 

  11. 11.

    Bloch KE, Iseli A, Zhang JN, Xie X, Kaplan V, Stoeckli PW, Russi EW (2000) A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment. Am J Respir Crit Care Med 162:246–251

    PubMed  CAS  Google Scholar 

  12. 12.

    Ferguson KA, Cartwright R, Rogers R, Schmidt-Nowara W (2006) Oral appliances for snoring and obstructive sleep apnea: a review. Sleep 29:244–262

    PubMed  Google Scholar 

  13. 13.

    Cartwright RD (1985) Predicting response to the tongue retaining device for sleep apnea syndrome. Arch Otolaryngol 111:385–388

    PubMed  CAS  Google Scholar 

  14. 14.

    Barthlen GM, Brown LK, Wiland MR, Sadeh JS, Patwari J, Zimmerman M (2000) Comparison of three oral appliances for treatment of severe obstructive sleep apnea syndrome. Sleep Med 1:299–305

    PubMed  Article  Google Scholar 

  15. 15.

    Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman JJ, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, Pancer JP (2006) Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An update for 2005. Sleep 29:240–243

    PubMed  Google Scholar 

  16. 16.

    Cartwright RD, Samelson CF (1982) The effects of a nonsurgical treatment for obstructive sleep apnea. The tongue-retaining device. JAMA 248:705–709

    PubMed  Article  CAS  Google Scholar 

  17. 17.

    Vazquez JC, Tsai WH, Flemons WW, Masuda A, Brant R, Hajduk E, Whitelaw WA, Remmers JE (2000) Automated analysis of digital oximetry in the diagnosis of obstructive sleep apnoea. Thorax 55:302–307

    PubMed  Article  CAS  Google Scholar 

  18. 18.

    Issa FG, Morrison D, Hadjuk E, Iyer R, Feroah T, Remmers JE, Whitelaw WA (1993) Digital monitoring of obstructive sleep apnea using snoring sound and arterial oxygen saturation. Sleep 16:S132

    PubMed  CAS  Google Scholar 

  19. 19.

    Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14:540–545

    PubMed  CAS  Google Scholar 

  20. 20.

    Lacasse Y, Godbout C, Series F (2002) Independent validation of the Sleep Apnoea Quality of Life Index. Thorax 57:483–488

    PubMed  Article  CAS  Google Scholar 

  21. 21.

    Mok WY, Lam CL, Lam B, Cheung MT, Yam L, Ip MS (2004) A Chinese version of the Sleep Apnea Quality of Life Index was evaluated for reliability, validity, and responsiveness. J Clin Epidemiol 57:470–478

    PubMed  Article  Google Scholar 

  22. 22.

    Hills M, Armitage P (1979) The two-period crossover clinical trial. Br J Clin Pharmacol 8:7–20

    PubMed  CAS  Google Scholar 

  23. 23.

    Ferguson KA (2003) The role of oral appliance therapy in the treatment of obstructive sleep apnea. Clin Chest Med 24:355–364

    PubMed  Article  Google Scholar 

  24. 24.

    Dort LC, Hussein J (2004) Snoring and obstructive sleep apnea: compliance with oral appliance therapy. J Otolaryngol 33:172–176

    PubMed  Article  Google Scholar 

  25. 25.

    Isono S, Remmers JE, Tanaka A, Sho Y, Nishino T (1996) Static properties of the passive pharynx in sleep apnea. Sleep 19:S175–S177

    PubMed  CAS  Google Scholar 

  26. 26.

    Ono T, Lowe AA, Ferguson KA, Fleetham JA (1996) A tongue retaining device and sleep-state genioglossus muscle activity in patients with obstructive sleep apnea. Angle Orthodontist 66:273–280

    PubMed  CAS  Google Scholar 

  27. 27.

    Flemons WW, Reimer MA (1998) Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med 158:494–503

    PubMed  CAS  Google Scholar 

  28. 28.

    Flemons WW, Reimer MA (2002) Measurement properties of the Calgary sleep apnea quality of life index. Am J Respir Crit Care Med 165:159–164

    PubMed  Google Scholar 

Download references


We are indebted to Dr. Ward Flemons and Dr. Willis Tsai for their helpful discussions.

Author information



Corresponding author

Correspondence to Leslie Dort.

Additional information

Research conducted at the University of Calgary, Calgary, Canada. Research in part funded by the Alberta Heritage Fund for Medical Research

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Dort, L., Brant, R. A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing. Sleep Breath 12, 369–373 (2008). https://doi.org/10.1007/s11325-008-0187-5

Download citation


  • Sleep disordered breathing
  • Tongue retaining devices
  • Oral appliances
  • Snoring
  • Randomized controlled trial