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Open Access 01-05-2018 | Sleep Breathing Physiology and Disorders • Original Article

Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial

Authors: Maurits H. T. de Ruiter, Linda B. L. Benoist, Nico de Vries, Jan de Lange

Published in: Sleep and Breathing | Issue 2/2018

Abstract

Purpose

The Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA.

Methods

This prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5–30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months’ follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed.

Results

Ninety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months (P < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h (P < 0.001), with no significant between-group difference (P = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group (P = 0.598).

Conclusions

The efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups.

Trial registration:

www.clinicaltrials.gov (NCT02045576).

Available only for authorised users

Senaratna CV, Perret JL, Lodge C, Lowe A, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC (2016) Prevalence of obstructive sleep apnea in the general population: a systematic review. Sleep Med Rev. https://doi.org/10.1016/j.smrv.2016.07.002

Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J (2015) Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med 3(4):310–318. https://doi.org/10.1016/S2213-2600(15)00043-0 CrossRefPubMedPubMedCentral

(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. https://doi.org/10.1093/sleep/22.5.667

Strollo PJ Jr, Rogers RM (1996) Obstructive sleep apnea. N Engl J Med 334(2):99–104. https://doi.org/10.1056/NEJM199601113340207 CrossRefPubMed

Cartwright RD (1984) Effect of sleep position on sleep apnea severity. Sleep 7(2):110–114CrossRefPubMed

Oksenberg A, Silverberg DS, Arons E, Radwan H (1997) Positional vs nonpositional obstructive sleep apnea patients: anthropomorphic, nocturnal polysomnographic, and multiple sleep latency test data. Chest 112(3):629–639CrossRefPubMed

Richard W, Kox D, den Herder C, Laman M, van Tinteren H, de Vries N (2006) The role of sleep position in obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol 263(10):946–950. https://doi.org/10.1007/s00405-006-0090-2 CrossRefPubMed

Mador MJ, Kufel TJ, Magalang UJ, Rajesh SK, Watwe V, Grant BJ (2005) Prevalence of positional sleep apnea in patients undergoing polysomnography. Chest 128(4):2130–2137. https://doi.org/10.1378/chest.128.4.2130 CrossRefPubMed

Hoekema A, Stegenga B, De Bont LG (2004) Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review. Crit Rev Oral Biol Med 15(3):137–155CrossRefPubMed

10.

Lim J, Lasserson TJ, Fleetham J, Wright J (2004) Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev 4:CD004435. https://doi.org/10.1002/14651858.CD004435.pub2

11.

Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE (2011) A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev 15(6):343–356. https://doi.org/10.1016/j.smrv.2011.01.003 CrossRefPubMedPubMedCentral

12.

Weaver TE, Grunstein RR (2008) Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc 5(2):173–178. https://doi.org/10.1513/pats.200708-119MG CrossRefPubMedPubMedCentral

13.

Vecchierini M, Attali V, Collet J, d’Ortho M, El Chater P, Kerbrat J, Leger D, Monaca C, Monteyrol P, Morin L, Mullens E, Pigearias B, Meurice J, investigator ftO (2016) A custom-made mandibular repositioning device for obstructive sleep apnoea–hypopnoea syndrome: the ORCADES study. Sleep Med 19:131–140CrossRefPubMed

14.

Doff MH, Finnema KJ, Hoekema A, Wijkstra PJ, de Bont LG, Stegenga B (2013) Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects. Clin Oral Investig 17(2):475–482. https://doi.org/10.1007/s00784-012-0737-x CrossRefPubMed

15.

Doff MH, Veldhuis SK, Hoekema A, Slater JJ, Wijkstra PJ, de Bont LG, Stegenga B (2012) Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects. Clin Oral Investig 16(3):689–697. https://doi.org/10.1007/s00784-011-0555-6 CrossRefPubMed

16.

Caples SM, Rowley JA, Prinsell JR, Pallanch JF, Elamin MB, Katz SG, Harwick JD (2010) Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep 33(10):1396–1407CrossRefPubMedPubMedCentral

17.

Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP, Group ST (2014) Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 370(2):139–149. https://doi.org/10.1056/NEJMoa1308659 CrossRefPubMed

18.

Zaghi S, Holty JE, Certal V, Abdullatif J, Guilleminault C, Powell NB, Riley RW, Camacho M (2016) Maxillomandibular advancement for treatment of obstructive sleep apnea: a meta-analysis. JAMA Otolaryngol Head Neck Surg 142(1):58–66. https://doi.org/10.1001/jamaoto.2015.2678 CrossRefPubMed

19.

Bignold JJ, Deans-Costi G, Goldsworthy MR, Robertson CA, McEvoy D, Catcheside PG, Mercer JD (2009) Poor long-term patient compliance with the tennis ball technique for treating positional obstructive sleep apnea. J Clin Sleep Med 5(5):428–430PubMedPubMedCentral

20.

van Maanen JP, Richard W, Van Kesteren ER, Ravesloot MJ, Laman DM, Hilgevoord AA, de Vries N (2012) Evaluation of a new simple treatment for positional sleep apnoea patients. J Sleep Res 21(3):322–329. https://doi.org/10.1111/j.1365-2869.2011.00974.x CrossRefPubMed

21.

Bignold JJ, Mercer JD, Antic NA, McEvoy RD, Catcheside PG (2011) Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device. J Clin Sleep Med 7(4):376–383. https://doi.org/10.5664/JCSM.1194 PubMedPubMedCentral

22.

van Maanen JP, Meester KA, Dun LN, Koutsourelakis I, Witte BI, Laman DM, Hilgevoord AA, de Vries N (2013) The sleep position trainer: a new treatment for positional obstructive sleep apnoea. Sleep Breath 17(2):771–779. https://doi.org/10.1007/s11325-012-0764-5 CrossRefPubMed

23.

van Maanen JP, de Vries N (2014) Long-term effectiveness and compliance of positional therapy with the sleep position trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep 37(7):1209–1215. https://doi.org/10.5665/sleep.3840 CrossRefPubMedPubMedCentral

24.

Benoist L, de Ruiter M, de Lange J, de Vries N (2017) A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea. Sleep Med 34:109–117. https://doi.org/10.1016/j.sleep.2017.01.024 CrossRefPubMed

25.

Berry RB, Brooks R, Gamaldo CE, Harding SM, Marcus C, Vaughn B (2012) The AASM manual for the scoring of sleep and associated events, Rules, terminology and technical specifications. American Academy of Sleep Medicine, Darien

26.

Bhuiyan P, Rege N (2001) ICH Harmonised Tripartite Guideline: guideline for good clinical practice. J Postgrad Med 47:45–50

27.

Eijsvogel MM, Ubbink R, Dekker J, Oppersma E, de Jongh FH, van der Palen J, Brusse-Keizer MG (2015) Sleep position trainer versus tennis ball technique in positional obstructive sleep apnea syndrome. J Clin Sleep Med 11(2):139–147. https://doi.org/10.5664/jcsm.4460 PubMedPubMedCentral

28.

Dieltjens M, Braem MJ, Vroegop AV, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM (2013) Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest 144(5):1495–1502. https://doi.org/10.1378/chest.13-0613 CrossRefPubMed

29.

Petit FX, Pepin JL, Bettega G, Sadek H, Raphael B, Levy P (2002) Mandibular advancement devices: rate of contraindications in 100 consecutive obstructive sleep apnea patients. Am J Respir Crit Care Med 166(3):274–278. https://doi.org/10.1164/rccm.2008167 CrossRefPubMed

30.

https://doi.org/10.1093/sleep/22.5.667

31.

(2001) ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med 47:45–50

Title: Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial
Authors: Maurits H. T. de Ruiter
Linda B. L. Benoist
Nico de Vries
Jan de Lange
Publication date: 01-05-2018
Publisher: Springer International Publishing
Published in: Sleep and Breathing / Issue 2/2018
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI: https://doi.org/10.1007/s11325-017-1568-4

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Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial

Abstract

Purpose

Methods

Results

Conclusions

Trial registration:

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Abstract

Purpose

Methods

Results

Conclusions

Trial registration:

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