Tongue retaining devices for obstructive sleep apnea: A systematic review and meta-analysis




Abstract


Objective


Tongue Retaining Devices (TRD) anteriorly displace the tongue with suction forces while patients sleep. TRD provide a non-surgical treatment option for patients with Obstructive Sleep Apnea (OSA). Our objective was to conduct a systematic review of the international literature for TRD outcomes as treatment for OSA.


Methods


Three authors independently and systematically searched four databases (including PubMed/MEDLINE) through June 26, 2016. We followed guidelines set within the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).


Results


Sixteen studies with 242 patients met criteria. The overall means ± standard deviations (M ± SD) for apnea-hypopnea index (AHI) decreased from 33.6 ± 21.1/h to 15.8 ± 16.0/h (53% reduction). Seven studies (81 patients) reported lowest oxygen saturation (LSAT), which improved from 79.8 ± 17.5% to 83.9 ± 8.6%. Four studies (93 patients) reported Epworth sleepiness scale (ESS), which decreased from 10.8 ± 4.8 to 8.2 ± 4.5, p < 0.0001. Four studies (31 patients) reported Oxygen Desaturation Index (ODI) which decreased from 29.6 ± 32.1 to 12.9 ± 8.7, a 56.4% reduction.


Conclusion


Current international literature demonstrates that tongue retaining devices reduce apnea-hypopnea index by 53%, increase lowest oxygen saturation by 4.1 oxygen saturation points, decrease oxygen desaturation index by 56% and decrease Epworth sleepiness scale scores by 2.8 points. Tongue retaining devices provide a statistically effective alternative treatment option for obstructive sleep apnea.


1


Introduction


Obstructive Sleep Apnea (OSA) remains a prevalent and difficult disease to treat . Treatment modalities range from the most non-invasive form such as lifestyle modifications to surgical procedures that permanently change the patient’s anatomy . Selection of a specific type of treatment remains largely based on parameters to address specific physiologic and anatomic variables that contribute to the obstructive etiology . In this fashion, Continuous Positive Airway Pressure (CPAP) serves as the gold standard in effectively addressing the obstruction throughout the upper airway .


Unfortunately, patient adherence proves difficult at times due to discomfort from wearing the CPAP mask as well as at times intolerable pressures necessary to relieve obstruction in patients requiring higher pressures . Consequently, patients frequently seek alternative treatment modalities to either replace or augment CPAP with the purpose of decreasing pressures and length of wear of the devices . Though surgical options provide a potential treatment modality to effectively address the patient’s anatomic obstructive pathology, the patient’s risk with surgery increases from the anesthesia as well as the surgical procedure itself . In addition, the typical co-morbidities associated with the elderly and prematurity of growth in the child increase the difficulty of effective treatment through surgery .


For the patient whose risk outweighs the gains associated with surgical intervention, or in patients who decline CPAP, other alternatives exist. Oral appliances provide a minimally invasive, typically non-permanent method of addressing the obstruction at specific points within the upper airway . One type of oral appliance, a tongue retaining device (TRD) employs a non-surgical technique of treating OSA by anteriorly displacing the tongue with suction forces while patients sleep [ Fig. 6 ]. It provides a non-invasive treatment option for patients with OSA for whom surgery appears contraindicated or too risky . TRD isolates the tongue and eliminates the need to move the mandible forward, unlike other oral appliances . In the USA, these devices are available for purchase directly by the patient from sites such as Amazon©, eBay© or with a prescription from companies such as Aveo based out of Canada ( www.getaveo.com ). We conducted a systematic review of the international literature for polysomnography and sleepiness data as treatment for adult OSA to assess the effectiveness of the TRD.




2


Materials and methods


Three authors (ETC, NBN and MC) independently searched the international literature without regard to language from inception of each database through June 26, 2016. Databases searched included PubMed/MEDLINE, Scopus, Google Scholar and The Cochrane Library. An example of a search strategy for PubMed/MEDLINE is: ((“tongue retain*” OR “tongue stabil*”) AND (OSA OR “apnea” OR “apnoea”)).


The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement and checklist were followed as much as possible during this review . Permission was obtained from the Tripler Army Medical Center Institutional Review Board for this study.


2.1


Study selection


Inclusion criteria for this review: (1) Patients : adults (≥ 18 years (y)) with OSA as assessed with polysomnography, (2) Intervention : oral device for retaining the tongue in an anterior position (3) Comparison : quantitative data pre- and post-TRD, (4) Outcome : sleep study data and sleepiness data, and (5) Study design : published and unpublished studies available within international databases. Exclusion criteria: (1) studies with other procedures performed and/or oral appliances used in addition to TRD (i.e. mandibular advancement device, oral pressure therapy devices (Winx)), and no sub-stratification made for TRD as a sole treatment; (2) studies using electrical power for suction to anteriorly displace the tongue; (3) studies with qualitative outcomes alone; and (4) patients exhibiting only central sleep apnea with no data revealing OSA .


2.2


Quality assessment of included studies


We used the National Institute for Health and Clinical Excellence (NICE) quality assessment tool to evaluate the quality of the studies . This tool allowed for a comparative assessment of studies exhibiting the same level of evidence (see Table 1 ).



Table 1

General characteristics and quality criteria of included studies.



































































































































































































































































Year, Study Study site N Follow up Evidence level Outcomes analyzed 1 2 3 4 5 6 7 8
Sutherland 2011 Australia 22 N/A 3b AHI, CM No Yes Yes Yes Yes Yes Yes Yes
Deane 2009 Australia 1 4 weeks 1b AHI, RDI No Yes Yes Yes Yes Yes Yes Yes
Kurtulmus 2009 Turkey 55 1 week 4 AHI, OVD No Yes No Yes No No Yes No
Lazard 2009 France 15 5 years 4 AHI, ESS No Yes Yes Yes No No Yes No
Younis 2009 Egypt 2 17 months 3b AHI, arousal index, ESS Yes Yes Yes Yes Yes No Yes Yes
Chen 2008 Canada 32 6 years 4 AHI Yes Yes No No Yes No Yes No
Dort 2008 Canada 8 3 weeks 1b ESS, RDI, Snoring, SAQLI No Yes Yes Yes Yes Yes Yes No
Higurashi 2002 Japan 6 3 months 3b ODI, SpO 2 No Yes No No Yes No Yes Yes
Kingshott 2002 New Zealand 5 2 nights 3b AHI, Snoring, OD, Arousal Frequency No Yes Yes No Yes No Yes No
Barthlen 2000 USA 14 1 year 3b AHI, SWS No Yes No Yes Yes No Yes Yes
Schonhofer 1997 Germany 7 6 months 3b AI, RDI, SaO 2 No Yes Yes Yes Yes No Yes Yes
Ono 1996 Canada 15 N/A 3b AI, AHI, THAT, GG EMG No Yes Yes Yes Yes No Yes No
Cartwright 1991 USA 12 8 weeks 1b AHI, ST No Yes No Yes Yes No Yes Yes
Cartwright 1988 USA 16 1 year 3b AHI No Yes Yes Yes Yes No Yes Yes
Cartwright 1985 USA 14 2 nights 3b AI No No No No Yes No Yes Yes
Cartwright 1982 USA 22 4–6 months 3b AI, OD No Yes No No Yes No Yes Yes

Quality assessment of cases series studies checklist from National Institute for Health and Clinical Excellence (NICE): 1) Was the case series collected in more than one center, i.e. multi-center study? 2) Is the hypothesis/aim/objective of the study clearly described? 3) Are the inclusion and exclusion criteria (case definition) clearly reported? 4) Is there a clear definition of the outcomes reported? 5) Were data collected prospectively? 6) Is there an explicit statement that patients were recruited consecutively? 7) Are the main findings of the study clearly described? 8) Are outcomes stratified? (e.g., by abnormal results, disease stage, patient characteristics)? Abbreviations: AHI = Apnea–Hypopnea index; ESS = Epworth Sleepiness Scale; LSAT = lowest oxygen saturation; MSAT = mean oxygen saturation; N.A. = Not applicable; N.R. = Not reported; RCR = retrospective case report; RCS = retrospective case series; RDI = respiratory disturbance index; SAT < 90% = time spent under oxygen saturation of 90%.


2.3


Statistical protocol


We established the null hypothesis for this meta-analysis as no difference between the pre- and post-TRD sleep study and sleepiness data. We employed existing statistical software, STATA 14.1 (StataCorp, College Station, Texas, USA) and Review Manager Software (REVMAN) version 5.3 (Copenhagen: The Nordic Cochrane Centre: The Cochrane Collaboration, 2014) throughout our meta-analysis. We identified a p -value < 0.05 as the value for statistical significance. Calculations with REVMAN provided the mean difference (MD), standardized mean difference (SMD) and 95% confidence interval [95% CI] for the respective data values within this meta-analysis. We defined the magnitudes of effect for SMD from Cohen’s guidelines (small = 0.2, medium = 0.5, and large = 0.8).


The Cochrane Q statistic (Q statistic) allowed for evaluation of heterogeneity with a parameter of a p-value ≤ 0.10 considered as statistically significant in heterogeneity . We defined the calculated inconsistency (I 2 statistic) as low inconsistency = 25%, moderate inconsistency = 50% and high inconsistency = 75%. Upon identifying heterogeneity, we performed a sensitivity analysis to determine which study or studies served as the source(s) of the heterogeneity. We reviewed pertinent graphs, tables, charts and other forms of data presentation to identify and define the established data parameters. In the absence of a reported standard deviation, we used the meta-analysis total combined value as an estimate of the standard deviation. We identified and combined any sub-stratified data for outcomes of individuals to provide one pre and post-operative value. We extracted only data pertinent to patients with OSA (AHI ≥ 5/h) for the meta-analysis. If we identified any missing data that is necessary for including studies into the meta-analysis, we made at least two attempts to contact the corresponding author listed within the research article.




2


Materials and methods


Three authors (ETC, NBN and MC) independently searched the international literature without regard to language from inception of each database through June 26, 2016. Databases searched included PubMed/MEDLINE, Scopus, Google Scholar and The Cochrane Library. An example of a search strategy for PubMed/MEDLINE is: ((“tongue retain*” OR “tongue stabil*”) AND (OSA OR “apnea” OR “apnoea”)).


The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement and checklist were followed as much as possible during this review . Permission was obtained from the Tripler Army Medical Center Institutional Review Board for this study.


2.1


Study selection


Inclusion criteria for this review: (1) Patients : adults (≥ 18 years (y)) with OSA as assessed with polysomnography, (2) Intervention : oral device for retaining the tongue in an anterior position (3) Comparison : quantitative data pre- and post-TRD, (4) Outcome : sleep study data and sleepiness data, and (5) Study design : published and unpublished studies available within international databases. Exclusion criteria: (1) studies with other procedures performed and/or oral appliances used in addition to TRD (i.e. mandibular advancement device, oral pressure therapy devices (Winx)), and no sub-stratification made for TRD as a sole treatment; (2) studies using electrical power for suction to anteriorly displace the tongue; (3) studies with qualitative outcomes alone; and (4) patients exhibiting only central sleep apnea with no data revealing OSA .


2.2


Quality assessment of included studies


We used the National Institute for Health and Clinical Excellence (NICE) quality assessment tool to evaluate the quality of the studies . This tool allowed for a comparative assessment of studies exhibiting the same level of evidence (see Table 1 ).



Table 1

General characteristics and quality criteria of included studies.



































































































































































































































































Year, Study Study site N Follow up Evidence level Outcomes analyzed 1 2 3 4 5 6 7 8
Sutherland 2011 Australia 22 N/A 3b AHI, CM No Yes Yes Yes Yes Yes Yes Yes
Deane 2009 Australia 1 4 weeks 1b AHI, RDI No Yes Yes Yes Yes Yes Yes Yes
Kurtulmus 2009 Turkey 55 1 week 4 AHI, OVD No Yes No Yes No No Yes No
Lazard 2009 France 15 5 years 4 AHI, ESS No Yes Yes Yes No No Yes No
Younis 2009 Egypt 2 17 months 3b AHI, arousal index, ESS Yes Yes Yes Yes Yes No Yes Yes
Chen 2008 Canada 32 6 years 4 AHI Yes Yes No No Yes No Yes No
Dort 2008 Canada 8 3 weeks 1b ESS, RDI, Snoring, SAQLI No Yes Yes Yes Yes Yes Yes No
Higurashi 2002 Japan 6 3 months 3b ODI, SpO 2 No Yes No No Yes No Yes Yes
Kingshott 2002 New Zealand 5 2 nights 3b AHI, Snoring, OD, Arousal Frequency No Yes Yes No Yes No Yes No
Barthlen 2000 USA 14 1 year 3b AHI, SWS No Yes No Yes Yes No Yes Yes
Schonhofer 1997 Germany 7 6 months 3b AI, RDI, SaO 2 No Yes Yes Yes Yes No Yes Yes
Ono 1996 Canada 15 N/A 3b AI, AHI, THAT, GG EMG No Yes Yes Yes Yes No Yes No
Cartwright 1991 USA 12 8 weeks 1b AHI, ST No Yes No Yes Yes No Yes Yes
Cartwright 1988 USA 16 1 year 3b AHI No Yes Yes Yes Yes No Yes Yes
Cartwright 1985 USA 14 2 nights 3b AI No No No No Yes No Yes Yes
Cartwright 1982 USA 22 4–6 months 3b AI, OD No Yes No No Yes No Yes Yes

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Aug 23, 2017 | Posted by in OTOLARYNGOLOGY | Comments Off on Tongue retaining devices for obstructive sleep apnea: A systematic review and meta-analysis

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