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
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.
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.
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).
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.
KeywordsObstructive sleep apnea Sleep position Positional therapy Oral appliance therapy Randomized controlled trial
- 1.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
- 2.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 CrossRefPubMedPubMedCentralGoogle Scholar
- 3.(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
- 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 CrossRefPubMedPubMedCentralGoogle Scholar
- 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 19:131–140CrossRefPubMedGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar
- 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 CrossRefPubMedGoogle Scholar
- 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 PubMedPubMedCentralGoogle Scholar
- 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, DarienGoogle Scholar
- 26.Bhuiyan P, Rege N (2001) ICH Harmonised Tripartite Guideline: guideline for good clinical practice. J Postgrad Med 47:45–50Google Scholar
- 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 CrossRefPubMedGoogle Scholar
- 31.(2001) ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med 47:45–50Google Scholar