The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study
2021; American Academy of Sleep Medicine; Volume: 17; Issue: 8 Linguagem: Inglês
10.5664/jcsm.9260
ISSN1550-9397
AutoresWaled M. Alshhrani, Mona M. Hamoda, Kentaro Okuno, Yuuya Kohzuka, John A. Fleetham, Najib Ayas, Robert Comey, Fernanda R. Almeida,
Tópico(s)Neuroscience of respiration and sleep
ResumoFree AccessScientific InvestigationsThe efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study Waled M. Alshhrani, BDS, MS, PhD(c), Mona M. Hamoda, BDS, MSc, MHSc, PhD(c), Kentaro Okuno, PhD, Yuuya Kohzuka, PhD, John A. Fleetham, MD, Najib T. Ayas, MD, Robert Comey, MD, Fernanda R. Almeida, DDS, MSc, PhD Waled M. Alshhrani, BDS, MS, PhD(c) Address correspondence to: Fernanda R. Almeida, DDS, MSc, PhD, and Waled M. Alshhrani, BDS, MS, PhD(c), Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, 2199 Wesbrook Mall, Vancouver, BC, Canada V6T 1Z3; Email: E-mail Address: [email protected] and E-mail Address: [email protected] Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, British Columbia, Canada Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, Riyadh, Saudi Arabia , Mona M. Hamoda, BDS, MSc, MHSc, PhD(c) Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, British Columbia, Canada , Kentaro Okuno, PhD Department of Geriatric Dentistry, Osaka Dental University, Hirakata-shi, Japan , Yuuya Kohzuka, PhD Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, Tokyo, Japan , John A. Fleetham, MD Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada , Najib T. Ayas, MD Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada , Robert Comey, MD Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada , Fernanda R. Almeida, DDS, MSc, PhD Address correspondence to: Fernanda R. Almeida, DDS, MSc, PhD, and Waled M. Alshhrani, BDS, MS, PhD(c), Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, 2199 Wesbrook Mall, Vancouver, BC, Canada V6T 1Z3; Email: E-mail Address: [email protected] and E-mail Address: [email protected] Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, British Columbia, Canada Published Online:August 1, 2021https://doi.org/10.5664/jcsm.9260Cited by:1SectionsAbstractEpubPDFSupplemental Material ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTStudy Objectives:To evaluate the short-term efficacy and self-reported outcomes of tongue-stabilizing device (TSD) therapy as compared to those of mandibular advancement device (MAD) therapy in an adult population diagnosed with obstructive sleep apnea.Methods:This study is a parallel, nonrandomized clinical trial of the TSD and MAD therapies. The efficacy of both interventions was evaluated objectively by level 3 home sleep apnea testing and by self-report using the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire, the Chalder Fatigue Scale, and the 36-Item Short-Form Health Survey. Adherence and adverse effects were self-reported.Results:Of the 39 patients who received TSD therapy, 27 managed to adapt and complete the trial and were matched with 26 patients who received MAD therapy. At the 2-month follow-up, the acceptance rate of the TSD therapy was 53.8%. Both patients receiving TSD therapy and patients receiving MAD therapy showed significant improvements in their respiratory event index (P < .05), with no difference between the treatments (P > .05). In those receiving TSD therapy (n = 27), the only self-reported efficacy measure that significantly improved with TSD therapy was the Chalder Fatigue Scale (P < .05). In contrast, all 4 self-reported measures (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, 36-Item Short-Form Health Survey, and Chalder Fatigue Scale) showed a significant improvement with MAD therapy.Conclusions:This study revealed similar improvements in apneas and oxygen saturation between TSD and MAD therapies. Whereas MAD therapy was a better treatment for obstructive sleep apnea in terms of daytime sleepiness and quality-of-life improvements, TSD therapy had a low treatment acceptance rate.Clinical Trial Registration:Registry: ClinicalTrials.gov; Name: The Efficacy of Tongue Stabilizing Device in Patients with Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02329925; Identifier: NCT02329925; and Registry: ClinicalTrials.gov; Name: Adherence and Preference of Continuous Positive Airway Pressure vs Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial (CHOICE); URL: https://clinicaltrials.gov/ct2/show/NCT02242617; Identifier: NCT02242617.Citation:Alshhrani WM, Hamoda MM, Okuno K, et al. The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study. J Clin Sleep Med. 2021;17(8):1607–1618.BRIEF SUMMARYCurrent Knowledge/Study Rationale: The clinical benefits of recently modified tongue-stabilizing devices for the treatment of obstructive sleep apnea have not been previously evaluated in clinical trials.Study Impact: A significant number of adults with obstructive sleep apnea who could tolerate a tongue-stabilizing device favorably responded to tongue-stabilizing device therapy in terms of respiratory event index, oxygen desaturation index, and fatigue measures; we concluded that this therapy can be used as a short-term alternative treatment option for obstructive sleep apnea. Regular follow-ups are required to manage potential adverse effects and monitor patients' adherence because only half of the patients could tolerate the treatment.INTRODUCTIONObstructive sleep apnea (OSA) is a chronic disease characterized by repetitive episodes of obstruction of the upper airway during sleep, resulting in sleep fragmentation and oxygen desaturation. Upon diagnosis, patients with OSA have the following available treatment options: (1) continuous or auto-adjusting positive airway pressure as a first-line treatment, (2) oral appliances (OAs), (3) adjunctive therapies, and (4) surgical treatment approaches with varying degrees of effectiveness.1 However, these treatment options have several limitations, including a lack of efficacy, poor patient adherence, and adverse effects.1An alternative OSA treatment option that has come to be increasingly used in recent years is OAs. The clinical practice guidelines of the American Academy of Sleep Medicine recommend using the mandibular advancement device (MAD) as a treatment for mild to moderate OSA; in addition, the MAD is also used for the treatment of severe OSA when patients are unable to tolerate or who refuse continuous positive airway pressure (CPAP) therapy or prefer the OA therapy.1 Overall, OA therapy may be broadly categorized into the following 2 main categories: (1) the MAD, which involves mechanically holding the mandible in a protruded position, and (2) the tongue-retaining device (TRD), which secures the tongue in a protruded position by creating suction on the tip of the tongue via a suction bulb.2The TRD is a custom-made appliance invented in 1982 by Charles Samelson as a treatment for patients with OSA.3 In the late 1990s, a noncustomized, preformed TRD—referred to as the tongue-stabilizing device (TSD)—was introduced by Christopher Robertson.4 The TSD was originally designed as a nontitratable universal device available in 4 different sizes. Several years later, to improve patient comfort, TSD materials were modified to include thinner, transparent Dow medical-grade silicone. The new TSD is a titratable device created using 4 mm and 7 mm titration accessories that further protrude the tongue; the device is available in 3 different sizes (see Figure 1).Figure 1: TSD and titration accessories.The TSD (A), the TSD with a 4-mm titration accessory (B), and the TSD with a 7-mm titration accessory (C). TSD = tongue-stabilizing device.Download FigureBased on available research and clinical experience, the American Academy of Dental Sleep Medicine developed an evidence-based definition of effective OAs for OSA treatment.5 According to this definition, effective OAs should be limited to customized titratable duo-block MADs; accordingly, OAs do not include TRDs and TSDs. Specific guidelines developed by the American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine in 2015 for the treatment of OSA and snoring using OAs reported insufficient evidence to evaluate the efficacy of TRDs in the treatment of adult patients with OSA.1 In 2017, a systematic review and meta-analysis study concluded that despite the scarcity of relevant publications, TRDs were a statistically effective alternative treatment option for the treatment of OSA in adults.6 Specifically, the review (16 articles) showed that, on average, TRDs reduced participants' apnea-hypopnea index (AHI) by 53% and the oxygen desaturation index (ODI) by 56%, increased the lowest oxygen saturation level by 4.1 oxygen saturation points, and decreased the Epworth Sleepiness Scale (ESS) score by 2.8 points.6Compared to MADs and TRDs, TSDs are more accessible and available for online purchase in the United States and Canada.6 However, only 4 previous studies investigated the efficacy, adherence, and adverse effects of TSD therapy in the treatment of adult OSA.4,7–9 In addition, only 1 observational study has analyzed the long-term effectiveness of TSD treatment.9 Using polysomnographic evaluation10 to assess TSD efficacy and treatment outcomes, the study revealed that the efficacy of TSDs was similar to that reported for MADs and that TSDs were generally well tolerated.9 However, it also found that at the 2-year follow-up, only 21.1% (16 out of 76) patients continued to use their TSDs and were included in the analysis. No details on the adverse effects of TSDs were reported.9The aim of the current clinical trial was to determine the efficacy of TSD therapy and compare TSD and MAD therapies in an adult population diagnosed with OSA. We hypothesized that TSD and MAD have similar effects on the reduction of sleep apnea events and improvement of sleepiness, quality of life (QOL), and fatigue.METHODSStudy designThis study was a phase 2, open-label, quasi-experimental, parallel, nonrandomized explanatory clinical trial with 2 treatment arms: the TSD arm and the external active control MAD arm. An external control arm offers a way to decrease the trial size, cost, and duration. The TSD arm was prospectively registered as a single-site single-arm trial in the US clinical trials registry ( ClinicalTrials.gov Identifier: NCT02329925) and was approved by the Clinical Research Ethics committee (H14-01333), University of British Columbia (UBC). The study protocol of the TSD single-arm trial was previously published.11 The data pertaining to the MAD arm were externally obtained from another clinical trial database12 registered with the clinical trials registry ( ClinicalTrials.gov Identifier: NCT02242617) and had ethical approval (H14-01215).ParticipantsThe TSD armPatients who were referred by a physician to the Frontier Clinical Research Centre/University of British Columbia dental sleep clinics (Vancouver, British Columbia, Canada) for an OA consultation during the recruiting period were eligible for inclusion in the study. Patients diagnosed with mild to severe OSA and those who had failed or refused CPAP therapy were invited to the trial. The patients were allocated to the therapy through a consecutive nonrandom process. The inclusion criteria were as follows: (1) ages ≥ 18 years, (2) objective diagnosis of OSA (5 ≤ AHI ≤ 50 events/h) documented in the past 5 years, and (3) body mass index (BMI) ≤ 35 kg/m2. Patients who had a neuromuscular disease, were taking medications that could affect sleep, or had ≤ 90% oxygen saturation levels for ≥ 20% of the night were excluded from the study.From June 2015 to June 2017, 79 patients diagnosed with OSA were eligible for the TSD study, and 41 accepted the invitation to participate in the trial. Of these, 2 patients failed the screening process because they were not interested in becoming study volunteers and decided to withdraw from the trial immediately after signing the consent form but before the initiation of the treatment. The final sample thus included a total of 39 patients.The TSD titration protocolThe flow chart for the TSD arm, including baseline assessment, intervention, titration, and follow-up assessment, is shown in Figure 2. Before the start of TSD therapy, all patients provided written informed consent, completed a set of questionnaires, received a standardized intraoral examination, and underwent baseline level 3 home sleep apnea testing (HSAT). Next, a TSD of a suitable size (small, medium, or large) along with standardized use and care instructions was provided to each patient. After an adaption period of at least a month, the participants underwent a second round of HSAT to objectively determine the TSD treatment efficacy. Subsequently, a titration protocol was initiated for the patients inadequately treated by the initial TSD (< 50% respiratory event index [REI] reduction). For the inadequately treated patients, the TSD was titrated to hold the patient's tongue further forward with a 4 mm titration accessory followed by a 1-month adaption period and follow-up HSAT. Similarly, if a patient was adherent with the 4 mm accessory and had an REI reduction < 50%, then an additional 3 mm advancement with a 7 mm titration accessory was prescribed for a 1-month period followed by HSAT. The clinical examination was repeated, and all patients completed the follow-up questionnaires after experiencing a satisfactory response to the treatment (REI < 5 events/h or a reduction of ≥ 50% in REI) or after the maximum amount of comfortable titration was achieved.Figure 2: Timeline and number of patients who stopped using the TSD over the course of the trial.TSD = tongue-stabilizing device.Download FigureA total of 39 patients with OSA were fitted with a TSD (Aveo-TSD, Innovative Health Technologies, Dunedin, New Zealand). Of these, 27 patients were able to complete the trial (thereafter referred to as TSD users).The MAD arm and titration protocolThe REDCap database with 75 patients undergoing a MAD trial was used to generate an external active control arm consisting of 26 patients (thereafter referred to as MAD users). The Somnodent Flex (SomnoMed Ltd, Sydney, Australia) MAD was used. Inclusion criteria included the following: (1) treatment-naïve participants, (2) age range 19–75 years, (3) BMI ≤ 35 kg/m2, (4) ≥ 8 teeth per arch, and (5) objective diagnosis of OSA (5 ≤ AHI ≤ 50 events/h or 5 ≤ respiratory disturbance index ≤ 50 events/h or ODI ≥ 10 events/h) documented in the past 2 years. Exclusion criteria were as follows: (1) extensive periodontal disease, (2) inability to protrude the jaw, (3) insufficient vertical opening, (4) uncontrolled renal or cardiovascular disease, and (5) nighttime ≤ 90% oxygen saturation levels ≥ 20% of the night. This arm was from a previous study that required patients to stay on the trial for 1.5 years. Therefore, the patients' exclusion criteria were more rigorous.All patients in the MAD arm provided written informed consent, completed a set of questionnaires, and performed baseline level 3 HSAT. The participants also underwent adjustment of their mandible position until the maximum comfortable mandibular advancement was achieved. In addition, to ensure adequate titration, the MAD titration was objectively evaluated by an oximeter, and the objective improvement was defined as an ODI < 5 events/h. After the titration period, the patients underwent a second round of HSAT to objectively determine the treatment's efficacy. The clinical examination was then repeated, and each patient completed follow-up questionnaires.MatchingThe purpose of matching the TSD and MAD arms was to ensure their comparability in terms of baseline characteristics, with a particular focus on the following 3 important confounding factors: age, baseline BMI, and baseline REI.13–15 To minimize selection bias during the matching process, the selection was made in chronological order and was blinded to all patients' data, with the exception of those 3 factors. The cutoffs used were age (≥ 50 years or < 50 years),16,17 BMI (≥ 30 kg/m2 or < 30 kg/m2),18,19 and REI (mild, 5–14.5 events/h, moderate, 15–29.5 events/h, or severe, ≥ 30 events/h). The first 26 patients in the MAD database who matched the TSD users were identified (see Figure 3).Figure 3: MAD arm selection process.BMI = body mass index, CFQ = Chalder Fatigue Scale, ESS = Epworth Sleepiness Scale, FOSQ-10 = Functional Outcomes of Sleep Questionnaire, HSAT = home sleep apnea testing, MAD = mandibular advancement device, RDI = respiratory disturbance index, SF-36v2 = 36-Item Short-Form Health Survey, version 2.Download FigurePortable monitoringThe participants' OSA severity was evaluated at baseline and after titration in both arms with level 3 HSAT. In the TSD arm, the patients underwent level 3 HSAT (MediByte, Braebon Medical Corporation, Kanata, Canada) with a sleep, cardiovascular, oximetry, position, effort, and respiratory classification of C4O1xP2E4R2 that involved the use of respiratory effort bands on the chest and abdomen and airflow analysis with a pressure transducer and pulse oximeter.20 In the MAD trial, the patients underwent level 3 HSAT (Alice NightOne, Respironics Inc., Peoria, IL) with a sleep, cardiovascular, oximetry, position, effort, and respiratory classification of C4O1P2E1R2.20 All sleep studies in both arms were manually scored according to the 2017 American Academy of Sleep Medicine scoring guidelines21 by the same sleep technologist, who was blinded to the patients' treatment allocation and trial timeline.Treatment outcome measuresObjective measuresThe primary outcome measures were a reduction in the REI and the 3% ODI. In addition, the REI was used to determine the treatment efficacy. Accordingly, the treatment results were defined as a complete success when the symptoms were resolved (ESS score < 11) and when the REI was < 5 with the use of the OA, as a partial success when the symptoms improved (ESS score decreased) and when a reduction of ≥ 50% in the REI was achieved but the REI remained at > 5 events/h, and as treatment failure when ongoing symptoms were present and/or the reduction in the REI was < 50%. For a between-treatments REI comparison, to compensate for using 2 different level 3 monitors we expressed the values as percentages of change.Self-reported measuresThe ESS was used to measure daytime sleepiness.22 To evaluate QOL, the patients completed the 36-Item Short-Form Health Survey (SF-36), version 2. In this study, we used a summary of emotional QOL (mental component summary) and physical QOL (physical component summary).23,24 A short 10-item version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10) was used to measure sleep-specific health-related QOL.25 The 11-item Chalder Fatigue Scale (CFQ) consists of 4 items for mental fatigue (range, 0–12) and 7 items for physical fatigue (range, 0–21), with higher scores indicating higher levels of fatigue.26Adverse effects and adherenceIn both treatment arms, adherence (indicated by the number of hours per night and nights per week worn) and adverse events were evaluated after completion of the titration period via a standardized clinical examination and a questionnaire previously used by our research group.27 Adherence was assessed based on the participants' responses to the questionnaires.Post hoc analysisBlood pressure (BP) records taken as part of routine clinical care were analyzed. All office BP readings were measured on a dental chair using an automated Omron BP monitor HEM-780 (Omron Healthcare, Kyoto, Japan) before baseline (pretreatment) and after titration for all patients in both study arms. For these measurements, the patient was in a seated position for at least 10 minutes, and we reported an average of 2 measurements of the left arm taken 5 minutes apart.Statistical analysisThe data were analyzed using univariate statistical analysis, and all variables are reported as mean ± standard deviation. Continuous quantitative independent variables were compared using the 2-sample t test for normally distributed variables and the Wilcoxon rank-sum test for skewed variables. Continuous quantitative dependent (within-group comparisons) variables were compared using the paired t test for normally distributed variables and the Wilcoxon signed-rank test for skewed variables. Categorical independent variables were compared using the chi-square test for normally distributed variables and the Fisher exact test for skewed variables. A statistical power analysis indicated that a sample size of at least 18 participants per arm was necessary to yield an 80% power (1-β) to detect a 10-point difference in the decrease of the REI with α = .05, and a 2-sided test based on the assumption that the within-patient standard deviation for the REI (based on night-to-night variability) was 10 points.8,28Quality Metric's Health Outcomes Scoring Software 5.0 (Quality Metric Inc., Lincoln, RI) was used to score the SF-36 data. All statistical analyses were performed using R Statistical Software version 3.3.1 (R Foundation for Statistical Computing, Vienna, Austria). GraphPad Prism version 8.0.0 for Mac OS X (GraphPad Software, San Diego, CA) was used to produce the graphs.RESULTSParticipantsTable 1 summarizes the characteristics of the TSD and MAD users. As seen in Table 1, no significant differences were found between the 2 groups for all reported characteristics. The participants' medications and/or medical conditions did not change over the course of the treatments.Table 1 Characteristics of the study population and differences between patients who were TSD-intolerant, TSD users, and MAD users.Characteristics of the Study PopulationTSD-Intolerant (n = 12/39)TSD Users (n = 27/39)MAD Users (n = 26)PaAge (y)46.8 ± 17.259.8 ± 12.355.9 ± 9.7NSbBaseline BMI (kg/m2)26.2 ± 3.827.5 ± 4.027.3 ± 3.9NScPost-treatment BMI (kg/m2)28.6 ± 3.627.7 ± 4.127.4 ± 4.1NScSex, male:female (% male)10:2 (83.3%)19:8 (70.4%)19:7 (73.1%)NScSystolic BP (mm Hg)120.5 ± 16.2125.6 ± 15.6131.6 ± 18.1NSbDiastolic BP (mm Hg)78.2 ± 11.380.1 ± 9.084.2 ± 10.9NSbLevel 3 HSAT REI (events/h)14.2 ± 15.617.3 ± 14.317.5 ± 13.2NSb ODI 3% (events/h)9.4 ± 9.812.9 ± 13.015.1 ± 11.4NSbBaseline ESS score9.3 ± 2.98.1 ± 4.89.8 ± 6.1NSbAll measurements were described as mean ± SD except sex. aTSD users group vs MAD users group. bNonparametric test. cParametric test. Statistically significant at P < .05. BMI = body mass index, BP = blood pressure, ESS = Epworth Sleepiness Scale, HSAT = home sleep apnea testing, MAD = mandibular advancement device, NS = not significant, ODI = oxygen desaturation index, REI = respiratory event index, SD = standard deviation, TSD = tongue-stabilizing device.Accordingly, 39 (100%) patients started TSD therapy. After receiving the initial TSD, 12 (30.8%) patients could not use it during the first month (the TSD adaptation period). These patients are referred to as the TSD-intolerant group. The remaining 27 (69.2%) patients managed to adapt and complete the trial (TSD users). In the TSD users group, the average use of TSD therapy was 106.0 (± 49.9) days after the TSD insertion. Two (7.4%) patients were fitted with the TSD with a 4 mm accessory. None of the patients could tolerate a 7 mm accessory. Further details regarding screening, titration, and withdrawal are provided in Figure 2. After completion of the trial, 6 (22.2%) patients immediately discontinued TSD therapy, whereas 21 (77.7%) continued using it. Therefore, the acceptance rate of the TSD therapy after 2 months was 53.8% (21 out of 39). In contrast, among the 26 patients fitted with the MAD, no withdrawal from the MAD therapy occurred during the trial. The average use of MAD therapy was 88.0 (± 54.0) days after the MAD insertion. The TSD size and efficacy are reported in Figure S1, Figure S2, Figure S3, and Figure S4 in the supplemental material.Treatment outcome measuresObjective measures (REI and ODI)In the TSD users group, there was a significant improvement in the REI (P < .05) and ODI (P < .05) (see Table 2). The REI and ODI averages decreased by 26% ± 77.8 and 63.9% ± 459 from baseline, respectively, and the mean residual REI was 9.0 ± 7.0 events/h. Nine (33.3%) patients were classified as a complete success, 8 (29.6%) as a partial success, and 10 (37.0%) as treatment failures. In the MAD users group, there was a significant improvement in the REI (37.0% ± 44.5, P < .05) and ODI (37.7% ± 43.2, P < .05; see Table 2 and Table S1, Table S3, Table S4, Table S5, and Table S6 in the supplemental material). The mean residual REI was 8.7 ± 6.7 events/h. Based on the HST in the MAD users group, 10 (38.5%) patients were categorized as complete successes, 6 (23.1%) as partial successes, and 10 (38.5%) as treatment failures. Figure 4 summarizes the TSD and MAD objective efficacy of the patients' measures. No significant differences in the efficacy of TSD as compared to MAD were observed (P > .05).Table 2 Sleep study (level 3), sleepiness, QOL, and fatigue self-reported data at baseline, after the 2-month treatment, and the amount of change (with statistical analysis of the amount of change between the treatments).Efficacy of OATSD Users (n = 27)MAD Users (n = 26)ΔTSD vs ΔMAD Pc (95% CI)Baseline2 MonthsΔTSDPa (95% CI)Baseline2 MonthsΔMADPb (95% CI)Objective measures (HSAT) REI (events/h)17.3 ± 14.39.0 ± 7.0–8.3 ± 12.8< .01*,d (2.7–11.7)18.0 ± 13.08.7 ± 6.7–8.8 ± 11.0< .01*,d (3.0–13.5).88d (–4.6 to 5.7) ODI 3% (events/h)13.0 ± 13.06.9 ± 5.5–6.1 ± 11.9< .01*,d (1.1–10.0)15.0 ± 11.08.0 ± 6.5–7.0 ± 8.9< .01*,d (2.7–10.1).39d (–2.5 to 5.6)Self-reported measures ESS score8.1 ± 4.87.2 ± 5.0–0.5 ± 2.8.67d (–1.0 to 1.5)9.8 ± 6.16.8 ± 4.7–2.9 ± 4.3< .01*,d (1.5–6.5).04*,d (1.3–3.0) SF-36 physical score50.2 ± 9.947.7 ± 11.4–2.2 ± 9.5.87d (–2.5 to 7.2)49.0 ± 8.152.0 ± 7.03.0 ± 7.4< .02*,d (–5.4 to –0.3).07d (–7 to 0.2) SF-36 mental score46.9 ± 9.649.1 ± 8. 02.2 ± 9.2.21d (–6.0 to 1.1)46 ± 1150.0 ± 103.7 ± 11.01*,d (–8.2 to –1.0).40d (–6.7 to 2.8) FOSQ-10 total score15.3 ± 3.015.6 ± 3.50.14 ± 2.2.51d (–1.2 to 0.6)15.0 ± 2.917.0 ± 3.21.6 ± 2.4< .01*,d (–2.5 to –1.1)< .01*,d (–2.7 to –0.5) CFQ total score15.5 ± 6.611.6 ± 6.0–3.8 ± 5.5< .01*,d (1.4–6.1)15.0 ± 7.012.0 ± 5.5–2.5 ± 4.4.01*,d (1.5–8.0).90d (–4.0 to 3.0) CFQ physical fatigue score10.4 ± 4.67.7 ± 4.8–2.7 ± 4.1.01*,d (1.5–6.0)9.7 ± 4.77.2 ± 3.7–2.4 ± 06.2.01*,d (1.0–0.0).67d (–3.0 to 2.0) CFQ mental fatigue score5.1 ± 2.54.0 ± 2.0–1.1 ± 2.2.02*,d (0.2–2.0)5.6 ± 2.84.6 ± 2.2–1.0 ± 2.4.03d (0.2–2.0).93d (–1.0 to 1.0)All measurements are described as mean ± SD. *Statistically significant at P ≤ .05. a2-month vs baseline within TSD users group. b2-month vs baseline within MAD users' group. cΔTSD vs ΔMAD. dNonparametric test. CFQ = Chalder Fatigue Scale, CI = confidence interval, ESS = Epworth Sleepiness Scale, FOSQ-10 = Functional Outcomes of Sleep Questionnaire-10, HSAT = home sleep apnea testing, MAD = mandibular advancement device, OA = oral appliance, ODI = oxygen desaturation index, QOL = quality of life, REI = respiratory event index, SD = standard deviation, SF-36 = 36-Item Short-Form Health Survey, TSD = tongue-stabilizing device, Δ = 2-month variable − baseline variable.Figure 4: Individual and average REI data for patients using TSD and MAD.MAD = mandibular advancement device, REI = respiratory event index, TSD = tongue-stabilizing device.Download FigureSelf-reported measures (ESS, FOSQ-10, SF-36, and CFQ)In the TSD users group, the only statistically significant self-reported efficacy measure that improved with the TSD intervention was the CFQ (P < .05). In contrast, all 4 self-reported measures (ESS, FOSQ-10, SF-36, and CFQ) showed a significant improvement after the MAD intervention. Moreover, the improvements in the ESS score and FOSQ-10 total score after the MAD intervention were significantly higher than the corresponding improvements after the TSD intervention (see Table 2 and Figure S5 in the supplemental material).Adverse effects and adherenceAs seen in Table 3, TSD users' self-reported adherence was lower—but not significantly—than MAD users' self-reported adherence (5.4 ± 2.2 nights/week vs 6.4 ± 1.3 nights/week, P = .03 and 5.7 ± 2.0 hours/night vs 6.8 ± 1.0 hours/night, P = .06, respectively).Table 3 Comparison of BP response and self-reported adherence to TSD and MAD treatments after the 2-month treatment.Efficacy of OATSD Users (n = 27)MAD Users (n = 26)ΔTSD vs ΔMAD Pc (95% CI)BaselineAfterΔTSDPa (95% CI)BaselineAfterΔMADPb (95% CI)Systolic BP (mm Hg)125.6 ± 15.6130.4 ± 15.75.5 ± 7.6< .01*,d (–8.1 to –2.2)132.0 ± 18.0128 ± 20–3.4 ± 15.0.39d (–3.5 to 8.5).01*,d (2.2–15.6)Diastolic BP (mm Hg)80.1 ± 9.080.4 ± 9.20.5 ± 7.2.68d (–3.8 to 2.7)84.0 ± 11.082.0 ± 13.0–2.5 ± 9.7.16d (–1.5 to 6.5).14d (–1.4 to 8.0)Adherence (nights/wk)5.4 ± 2.26.4 ± 1.3.03*,d (–2.0 to –2.5)Adherence (h/night)5.7 ± 2.06.8 ± 1.0.06d (–1.0 to 7.0)Length of OA usage (d)106.0 ± 49.988.0 ± 54.0.07d (–1.0 to 41.0)All measurements were described as mean ± SD. *Statistically significant at P ≤ .05. a2-month vs baseline within TSD users group. b2-month vs baseline within MAD users group. cΔTSD vs ΔMAD. dNonparametric test. BP = blood pressure, CI = confidence interval, MAD = mandibular advancement device, OA = oral appliance, SD = standard deviation, TSD = tongue-stabilizing device, Δ = 2-month variable − baseline variable.Table 4 shows the self-reported frequency of adverse effects among TSD and MAD users. All pa
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