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 Table of Contents  
REVIEW
Year : 2022  |  Volume : 22  |  Issue : 4  |  Page : 314-327

To compare different non-surgical treatment modalities on treatment of obstructive sleep apnea: A systematic review and meta-analysis


1 Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh, India
2 Department of Conservative Dentistry and Endodontics, King George's Medical University, Lucknow, Uttar Pradesh, India

Date of Submission25-May-2022
Date of Decision28-Jul-2022
Date of Acceptance29-Jul-2022
Date of Web Publication03-Oct-2022

Correspondence Address:
Balendra P Singh
Department of Prosthodontics, Faculty of Dental Sciences, King George's Medical University, Lucknow, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jips.jips_261_22

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  Abstract 


The study aimed to assess the effect of mandibular advancement device (MAD) in patients with obstructive sleep apnea for reduction in 24-h mean blood pressure, sleep quality, Apnea Hypopnea Index (AHI), and patient compliance, compared to continuous positive airway pressure (CPAP), other interventions, or no treatment. Three different databases such as PubMed, EMBASE, and CENTRAL were searched using different search terms till July 2021 as per the inclusion and exclusion criteria. After inclusion of studies, data extraction including risk of bias assessment was done. For each study, we used odds ratio, mean difference, and 95% confidence interval to assess and synthesize the outcomes. The quality of evidence was evaluated as per the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Twenty-one randomized controlled trials were included: 497 patients in the MAD group, 239 patients in the CPAP group, and 274 patients in the sham group. In MAD-CPAP comparison, the results favored CPAP in the reduction of AHI of 3.48 (1.76-5.19). However, unclear results were found for sleep quality measured as Epworth Sleepiness Scale (ESS), patient compliance, and 24-h mean blood pressure. In MAD-sham comparison, the results favored MAD in the reduction of AHI of − 8.39 (−10.90–−5.88] and ESS of − 0.91 (−1.70–−0.12) and favored sham in terms of patient compliance while, unclear results for 24-h mean blood pressure. The GRADE score indicated that the quality of evidence is very low, low, and moderate for different outcomes. CPAP in comparison to MAD and MAD in comparison to sham showed a significant AHI reduction. However, patient compliance and 24-h mean blood pressure were not significantly different in MAD-CPAP or MAD-sham. Quality of evidence is very low and low when MAD was compared with CPAP and sham, respectively, for AHI.

Keywords: Continuous positive airway pressure, obstructive sleep apnea, oral appliance, systematic review and meta-analysis


How to cite this article:
Vimal J, Dutt P, Singh N, Singh BP, Chand P, Jurel S. To compare different non-surgical treatment modalities on treatment of obstructive sleep apnea: A systematic review and meta-analysis. J Indian Prosthodont Soc 2022;22:314-27

How to cite this URL:
Vimal J, Dutt P, Singh N, Singh BP, Chand P, Jurel S. To compare different non-surgical treatment modalities on treatment of obstructive sleep apnea: A systematic review and meta-analysis. J Indian Prosthodont Soc [serial online] 2022 [cited 2022 Nov 30];22:314-27. Available from: https://www.j-ips.org/text.asp?2022/22/4/314/357796




  Introduction Top


Obstructive sleep apnea (OSA) is sleep-related breathing disorder. OSA if left untreated may lead to poor quality of life (QoL), increased chances of road traffic accidents, cardiovascular attack, endocrine, metabolic, urogenital, neurological other systemic disorders like hypertension.[1],[2],[3] The prevalence of OSA is 2%–4% in adult population.[4] Gold standard test to diagnose OSA is polysomnography through Apnea Hypopnea Index (AHI), which also indicates severity of OSA. Symptoms of OSA can be daytime and nighttime. Daytime symptoms include daytime sleepiness, morning headache, difficulty in concentration during daytime, awakening with dry mouth or sore throat, experiencing mood changes, and memory loss. Nighttime symptoms include apnea, gastroesophageal reflux disease, loud snoring during sleep, road traffic accidents, decreased libido, sexual dysfunction, and bruxism.[5],[6],[7] Treatment of OSA can be surgical or nonsurgical. Surgical management includes pharyngoplasty, uvulopalatopharyngoplasty, nasal surgery, tonsillectomy in adults, genioglossus advancement, maxillomandibular advancement, and adenoidectomy, but these are not acceptable to many patients[8] due to its invasiveness. Nonsurgical management includes continuous positive airway pressure (CPAP), oral appliances (OAs) like mandibular advancement device (MAD) and act as conservative treatment options.[9],[10]

CPAP is used as therapeutic as well as diagnostic for OSA patient.[11],[13],[14] CPAP works to keep the airway open and therefore prevents airway collapse, improves quality of sleep, reduces mortality rate, reduces high blood pressure, and reduces sympathetic tone during daytime and nighttime.[15],[16],[17],[18],[19],[20]

OA improves upper airway configuration and prevents airway collapse through alteration in positions of jaw and tongue.[21],[22],[23],[24] OA for OSA patients can either be tongue retaining devices/MADs.[25] The mechanism of action is to protrude the lower jaw more anteriorly and pulls the genioglossus forward, which helps in forward movement of the tongue. This forward movement of the tongue creates more upper airway space, which reduces chances of snoring and improves symptoms of OSA.[25] These OAs are active and protrusion of the mandible can be titrated to various degree according to the need. These are named as MAD or mandibular-repositioning appliance.[26],[27]

MADs are popular choice to patients as these are affordable, light weight, and easy to use than CPAP. CPAP is a complete assembly having mask which is attached to the patient's face.[28] This may not be easily acceptable by the patient. Therefore, MADs are recommended in mild-to-moderate obstructive sleep apnea cases.[28],[29],[30] This device also stated to eliminate compliance issues with CPAP and therefore may be a treatment of choice for CPAP-intolerant patients.[28]

Sham is nonactive MAD which can be given in upper or lower arch as placebo. Sham has similar design as active MAD or just in the form of a plate with no components attached to it, but unlike active MAD, these do not protrude mandible. Few studies showed no significant change in blood pressure and sleep quality between MAD and sham appliance.[1] Hence, to find the true treatment effect of these physical therapies and to avoid the effect due to possibility of regression to the mean or placebo effect, a comparison with sham is important.

Efficacy of these treatments in OSA was assessed by measuring AHI, sleep quality, blood pressure, snoring events, nocturnal oxygenation, QoL, neurocognitive behavior, and patient compliance. Hence, the aim of the study was to assess the effect of MAD in comparison with CPAP and sham or no treatment for reduction in 24-h blood pressure, sleep quality, AHI, and patient compliance.


  Methods Top


This meta-analysis was registered in PROSPERO[31] (CRD42020131068) and followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) system.[32] The following databases were searched: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (from 1946 onwards); and EMBASE. Only English-language articles were included without any restriction on date of publication to compare MAD with CPAP, sham, or no appliance in patients with OSA. Details of PICO of meta-analysis were

  1. Population (P) was OSA.
  2. Intervention (I) were MAD or mandibular-repositioning device, mandibular protrusion.
  3. Comparison (C) were CPAP, sham, occlusal splints, or no appliance.
  4. Outcomes (O) were reduction in 24-h mean blood pressure, sleep quality (Epworth Sleepiness Scale [ESS]), AHI and patient compliance.


Various search terms including MeSH and Emtree were used as per attached [Supplementary Table 1] for different databases. These terms were then combined with different Boolean operator like “AND” or “OR” or “NOT.” The authors (JV, PD, and BPS) have done search in these databases. Manual search of reference list of the included studies was also done by one author (PC). Duplicates were removed in EndNote (version 19), and all articles were exported from EndNote to Covidence[33] for screening of abstracts and full text. Abstract followed by full-text screening was done by the two different reviewers (JV and PD) independently and the third reviewer (BPS) resolved conflicts for screening done by the two reviewers. After full-text screening, data extraction including risk of bias assessment was done in Covidence.



Criteria for study selection

Inclusion criteria for the study were randomized controlled trial (RCT), cross-over trial (first period data were taken), following the above-mentioned PICO criteria, and published in English.

Exclusion criteria for the study were duplicate studies, studies with data errors, irrelevant outcome, case report, letter to editor, conference proceeding, systematic review, or meta-analysis.

For the included studies, data extraction and risk of bias assessment were done in Covidence[33] by the two reviewers (JV and PD) independently and consensus was reached after. For any conflicts, the third reviewer (BPS) was consulted. Data extraction was done in data extraction form of all studies in five sections:

  1. Identification details included sponsorship source, country, study setting, author, E-mail, and publication details
  2. Methods included design of the study, aim of the study, duration of the study, ethical approval, key conclusions of the study, method of recruitment of patients, and null hypothesis
  3. Population included inclusion criteria, exclusion criteria, any group difference, population description, total number randomized, withdrawals, and exclusion of patients
  4. Intervention and comparison group included total number randomized, type of intervention and with device or appliance details, number of visits, duration of follow-up, and resource requirement
  5. Outcome included AHI, ESS, 24-h mean blood pressure, and patient compliance.


Data analysis was finally filled in RevMan 5.4 software[34] for statistical analyses. For missing data, the corresponding author of studies was contacted.

Risk of bias assessment: It was done as per the Cochrane Handbook of Systematic Review[35] using RoB 1.0 (Risk of Bias 1.0) having following domains: sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessor, incomplete outcome, selective outcome reporting, and other bias if any. Risk of bias assessment was selected for each domain as of low, high, or unclear risk of bias with supporting comments mentioned in the article.

A fixed-effects model was used for meta-analysis to generate forest plot using instructions as mentioned in the Cochrane Handbook of Systematic Reviews.[35] Heterogeneity was assessed using I2 statistic; if I2 value was >50%, it was considered substantial heterogeneity. Quality of evidence was assessed through the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) recommendation.[36],[37]


  Results Top


Databases were searched till July 2021; out of 305 articles, 41 studies met the inclusion criteria after full-text screening. Twenty-one studies were included for meta-analysis because outcome values in 20 articles could not be synthesized quantitatively.[16],[38],[39],[40],[41],[42],[43],[44],[45],[46],[47],[48],[49],[50],[51],[52],[53],[54],[55],[56 The study filtering process is depicted in PRISMA flowchart [Supplementary Figure 1].



Summary of characteristic of the included studies is presented in [Table 1]. Out of 21 studies,[17],[19],[22],[23],[57],[58],[59],[60],[61],[62],[63],[64],[65],[66],[67],[68],[69],[70],[71],[72],[73] 11 studies compared MAD and CPAP, while 10 studies compared MAD and sham.
Table 1: Basic characteristics of included studies

Click here to view


In most studies, the follow-up period was 6–12 weeks, but only one longitudinal study[60] has 10 years of follow-up. Two studies are same except the study by Aarab et al.,[47] which was 1-year follow-up of Aarab et al.[16] Hence, these two studies were merged for risk of bias assessment.

Summary of risk of bias assessment and risk of bias graph is shown in [Figure 1]. In sequence generation, 70% of studies showed low risk of bias and 30% showed unclear risk of bias. Methods of sequence generation were computer-generated random number,[23],[38],[42],[48],[52],[53],[54],[56],[59],[62],[65],[68],[69],[73],[74] block randomization,[16],[22],[43],[44],[47],[60],[71] and block of four.[40],[67] Many studies did not mention method of sequence generation.[17],[19],[39],[41],[45],[46],[50],[51],[57],[58],[61],[63],[64],[66],[70],[72],[75]
Figure 1: Risk of bias summary and risk of bias graph

Click here to view


In allocation concealment, 27% of studies showed low risk of bias, 27% showed unclear risk of bias, and 45% showed high risk of bias. Methods of allocation concealment used were sealed opaque envelope,[16],[23],[47],[52],[65],[66],[68] telephonic allocation,[69] flipping card,[50] sequence of arrival,[48] software,[45] and method not mentioned.[17],[19],[20],[22],[38],[39],[40],[41],[42],[43],[44],[46],[49],[51],[53],[54],[55],[58],[59],[60],[61],[62],[63],[64],[67],[70],[71],[72],[73]

In blinding of participants and personnel, 65%, 20%, and 15% of studies showed low, unclear, and high risk of bias, respectively. In blinding of outcome assessor, 65%, 25%, and 10% of studies showed low, unclear, and high risk of bias, respectively.

In incomplete outcome data, 67%, 27%, and 5% of studies showed low, unclear, and high risk of bias, respectively. In selective outcome reporting, 32% and 67% of studies showed low and unclear risk of bias, respectively. Few studies mentioned trial registry number and published studies followed trial document.[17],[23],[38],[48],[52],[57],[60],[65],[68],[71],[73]

The GRADE score was very low, low, and moderate for different outcomes and for comparison of MAD-CPAP and MAD-sham or no treatment as shown in [Table 2]. The main reasons of downgrading of quality were indirectness, high risk of bias, and imprecision.
Table 2: Summary of finding table of MAD versus Sham or no treatment (above) and MAD versus CPAP (below) using GRADE approach

Click here to view


Forest plot comparing AHI between MAD and sham included nine studies having 237 patients in the MAD group and 233 patients in the sham group [Figure 2]. Out of nine studies, 5 studies[59],[62],[65],[66],[70] favored the MAD, but 4 studies[63],[64],[69],[71] gave unclear result. Compared with sham, MAD significantly decreased AHI (weighted mean difference: 8.39, 95% confidence level [CI]: 10.90–5.88). [Figure 2] also depicts comparison of AHI between MAD and CPAP. Two studies[17],[58] favored CPAP and two studies[60],[19] gave unclear results. Compared with MAD, CPAP significantly decreased AHI (weighted mean difference [WMD]: 7.77, 95% CI: 5.89–9.66).
Figure 2: Forest plot interpretation of MAD-sham (above) and MAD-CPAP (below) for AHI. MAD: Mandibular advancement device, CPAP: Continuous positive airway pressure, AHI: Apnea Hypopnea Index

Click here to view


Forest plot comparing 24-h mean blood pressure between MAD and sham included 113 patients in the MAD group and 116 patients in sham [Figure 3]. Three studies included for this outcome and showed unclear result. [Figure 3] also shows comparison between MAD and CAPA and found unclear result (WMD: 0.50, 95% CI: −3.41~2.41).
Figure 3: Forest plot interpretation of MAD-sham (above) MAD-CPAP (below) for 24-h mean blood pressure. MAD: Mandibular advancement device, CPAP: Continuous positive airway pressure

Click here to view


Forest plot comparing ESS between MAD-sham included nine studies having 249 patients in the MAD and 248 in the CPAP groups [Figure 4]. Out of 9 studies, one study[73] favored MAD than sham, and the remaining 8 studies showed unclear result. In comparison to MAD and sham, MAD significantly reduces ESS (WMD: 0.91 CI: −1.70 ~ −0.12). [Figure 4] also depicts forest plot of MAD-CPAP for ESS, in which 8 studies were included. For 3 months of follow-up, seven studies favored CPAP than MAD (WMD: 0.31, 95% CI: −0.38~1.01).
Figure 4: Forest plot interpretation of MAD-sham (above) MAD-CPAP (below) comparison for ESS. MAD: Mandibular advancement device, CPAP: Continuous positive airway pressure, ESS: Epworth sleepiness scale

Click here to view


Forest plot comparing patient compliance between MAD and sham showed 100 patients for MAD and 902 patients for sham group [Figure 5]. All three studies showed unclear results. Compared with MAD, sham significantly showed better patient compliance (WMD: 0.84 CI: 0.32–1.36) [Figure 5] also shows comparison between MAD and CPAP with unclear result (WMD: 0.24, 95% CI: −2.27~2.74).
Figure 5: Forest plot interpretation for MAD-sham (above) MAD-CPAP (below) for patient compliance. Mandibular advancement device, CPAP: Continuous positive airway pressure

Click here to view



  Discussion Top


This meta-analysis compared MAD with CPAP, sham in obstructive sleep apnea patients for AHI, ESS, 24-h mean blood pressure, and patient compliance.

Most of the studies have at least one high risk of bias mainly in allocation concealment, blinding of participants, and outcome assessor. Many studies did not register prospectively in clinical trial registry which may lead to presenting selective outcome reporting for beneficial outcomes only. This leads to negative impact on certainty of evidence and future studies should focus on methodology for adequate allocation concealment, blinding, and trial registration.

Comparison of outcomes between mandibular advancement device and continuous positive airway pressure

In MAD-CPAP comparison, CPAP showed 3.48 times (ranged from 1.76 to 5.19 times) AHI reduction in comparison to MAD, but certainty of evidence is very low. CPAP is a device which creates pressure stent to open anatomical collapse of upper airway. It comes as an air pressure creating device with tube. The tube may be attached with nasal mask or face mask or simple nasal prongs. CPAP may show 24% better compliance (ranged from − 2.27 to 2.74) to MAD due to otorhinolaryngological reasons in nasal cavity and/or paranasal sinuses such as anatomical, physiological, or pathological. Other reasons of compliance with CPAP may be related to duration of use for effectiveness (>4 h use), side effects such as dermatitis, leakage from mask, claustrophobia, discomfort in nose, and rhinitis. Hence, patients who have mild-to-moderate OSA, not suitable for MAD treatment, or did not get improvement by MAD may take advise from sleep physician or dentist for CPAP. CPAP is also recommended in patients with controlled epilepsy, edentulous, or poor dentition. In case of poor compliance, low adherence due to side effect, or higher cost of CPAP, MAD is a treatment of choice, especially in short term. A meta-analysis by Li et al.[75] showed a similar finding with significantly decreased AHI by CPAP over MAD, but no significant difference in ESS. Another meta-analysis by Schwartz et al.[30] showed significantly decreased AHI in CPAP group in comparison to oral appliance. A study of Schwartz et al. also showed significantly lower compliance of CPAP in comparison to MAD. Studies showed that MADs have better compliance and QoL than CPAP, which leads to favorable side effects, increased usage time, and low rate of withdrawal.[68]

Comparison of outcomes between mandibular advancement device and sham

In MAD-sham comparison, results favored MAD in reduction of AHI, ESS and favored sham for patient compliance and unclear results for 24-h mean blood pressure. MAD is a jaw-repositioning device that repositions the jaw by forwardly protruding mandible and hyoid bone, thus preventing upper airway collapse by contracting genioglossus and increasing retroglossal distance. It has been determined by videoendoscopic and magnetic resonance imaging studies that MAD primarily increases the upper airway volume at velopharyngeal level.[56] The forward advancement of the mandible elevates the base of the tongue and stretches the soft palate, thus helping in improving the air patency. This systematic review also found various designs of MAD, which might influence outcome values.

Earlier data suggest that inactive OA (sham) played a role in the treatment of OSA and may help in lowering AHI levels. However, various RCTs have concluded better efficiency of MAD over sham appliance or placebo.[57],[58],[59],[60],[61],[62],[63]

This study suggests the use of CPAP or MAD in mild-to-moderate OSA. For severe apnea, CPAP is still treatment of choice. For noncompliant patients with CPAP, MAD is recommended and vice-versa if feasible. However, patient education including anatomical, physiological, and pathological condition should be considered for effective treatment.

The GRADE results showed low or very low quality of evidence due to indirectness, high risk of bias in allocation concealment, blinding of participants, outcome assessors, and inconsistency due to heterogeneity in studies. Reason of indirectness was due to various designs of CPAP or MAD was used in different studies.

Various databases were searched: PubMed, CENTRAL, and EMBASE to search the relevant studies related to this meta-analysis. The results of this review are applicable to mild-to-moderate OSA patients with no restriction of gender and age range from 24 to 55 years.

However, there are certain limitations to the present analysis, which are as follows: (1) the number of included studies is limited; (2) individual studies differed in exclusion/inclusion criteria; (3) the courses and detail of therapy were varied; (4) the severity of OSA in patients varied between studies; and (5) pooled data were analyzed, as individual patient data was not available, precluding more in-depth analyses.


  Conclusion Top


Continuous positive air pressure significantly reduces AHI in obstructive sleep apnea patients, but quality of evidence is very low in comparison to MAD. Patient compliance and 24-h mean blood pressure were not significantly different when MAD was compared to sham.

Acknowledgment

Funding provided by the Department of Science and Technology, State S and T Programme, New Delhi. ST/SSTP/UP/43/2017-18 (G) (DST, New Delhi) and 486/R.Cell-19 dated June 25, 2019 (KGMU, Lucknow).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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