Control of Tongue Position in Patients with Obstructive Sleep Apnea: Concept and Protocol for a Randomized Controlled Crossover Trial.

We hypothesize that the control of tongue position using a newly developed tongue position retainer, where the tongue is held in a protruded position (i.e., intervention A) or in its resting position (i.e., intervention B), is effective for maintaining upper airway patency in obstructive sleep apnea (OSA) compared with no control of tongue position. This is a randomized, controlled, non-blinded, crossover, and two-armed trial (i.e., sequence AB/BA) in 26 male participants (i.e., sample size) who are scheduled to undergo a dental operation under intravenous sedation with OSA (10 ≤ respiratory event index < 30/h). Participants will be randomly allocated into either sequence by a permuted block method, stratified by body mass index. Under intravenous sedation, participants will undergo two interventions, separated by a washout period after receiving intervention A or intervention B using a tongue position retainer after baseline evaluation, before each intervention is provided. The primary outcome is the abnormal breathing index of apnea as determined by the frequency of apnea per hour. We expect that, compared with no control of tongue position, both intervention A and intervention B will improve the abnormal breathing events with superior effects achieved by the former, offering a therapeutic option for OSA.

Compliance and side effects of tongue stabilizing device in patients with obstructive sleep apnea.

Objective: To evaluate the long-term effectiveness, compliance, and side effects of tongue stabilizing devices (TSDs).Methods: Thirty-nine patients were followed up after 12 and 30 months. The subjective effectiveness was assessed using the Epworth Sleepiness Scale (ESS), the Functional Outcomes Sleep Questionnaire (FOSQ-10), the Chalder Fatigue Scale (CFQ), and a sleep-related quality of life questionnaire (QoL). Compliance and side effects were assessed.Results: At 12-months, 35.9% of patients confirmed continuing the therapy, compared to only 15.4% of patients at 30 months. At 30 months, a significant average improvement of ESS (2.0 ± 2.8) was observed compared to baseline levels in six patients. Six patients demonstrated an average increase in blood pressure. The most frequently reported side effects were mouth dryness and excessive salivation. The 3D analysis revealed small tooth movements.Conclusion: The TSD therapy demonstrated a good long-term subjective effectiveness against OSA but had a relatively low treatment acceptance rate.

The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study.

STUDY 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.

Tongue Stabilizing Device-Emergent Central Sleep Apnea: A Case Report.

ABSTRACT: Treatment-emergent central sleep apnea is a phenomenon that has been reported after many obstructive sleep apnea treatment modalities. We present a case of demonstrating treatment-emergent central sleep apnea while using the tongue stabilizing device therapy. This case adds to the evidence that showed the effect of the supine position on the severity of central sleep apnea and shows the advantage of polysomnography follow-up after oral appliance therapy for central apnea assessment.

Nasopharyngeal Tube Effects on Breathing during Sedation for Dental Procedures: A Randomized Controlled Trial.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Dental procedures under sedation can cause hypoxic events and even death. However, the mechanism of such hypoxic events is not well understood. WHAT THIS ARTICLE TELLS US THAT IS NEW: Apnea and hypopnea occur frequently during dental procedures under sedation. The majority of the events are not detectable with pulse oximetry. Insertion of a nasal tube with small diameter does not reduce the incidence of apnea/hypopnea. BACKGROUND: Intravenous sedation is effective in patients undergoing dental procedures, but fatal hypoxemic events have been documented. It was hypothesized that abnormal breathing events occur frequently and are underdetected by pulse oximetry during sedation for dental procedures (primary hypothesis) and that insertion of a small-diameter nasopharyngeal tube reduces the frequency of the abnormal breathing events (secondary hypothesis). METHODS: In this nonblinded randomized control study, frequency of abnormal breathing episodes per hour (abnormal breathing index) of the patients under sedation for dental procedures was determined and used as a primary outcome to test the hypotheses. Abnormal breathing indexes were measured by a portable sleep monitor. Of the 46 participants, 43 were randomly allocated to the control group (n = 23, no nasopharyngeal tube) and the nasopharyngeal tube group (n = 20). RESULTS: In the control group, nondesaturated abnormal breathing index was higher than the desaturated abnormal breathing index (35.2 [20.6, 48.0] vs. 7.2 [4.1, 18.5] h, difference: 25.1 [95% CI, 13.8 to 36.4], P < 0.001). The obstructive abnormal breathing index was greater than central abnormal breathing index (P < 0.001), and half of abnormal breathing indexes were followed by irregular breathing. Despite the obstructive nature of abnormal breathing, the nasopharyngeal tube did not significantly reduce the abnormal breathing index (48.0 [33.8, 64.4] h vs. 50.5 [36.4, 63.9] h, difference: -2.0 [95% CI, -15.2 to 11.2], P = 0.846), not supporting the secondary hypothesis. CONCLUSIONS: Patients under sedation for dental procedure frequently encounter obstructive apnea/hypopnea events. The majority of the obstructive apnea/hypopnea events were not detectable by pulse oximetry. The effectiveness of a small-diameter nasopharyngeal tube to mitigate the events is limited.

Oral Appliances for the Management of OSA: An Updated Review of the Literature.

Oral appliances (OAs) are becoming increasingly recognized not only as an alternative to but also possibly as an adjunct treatment modality for OSA. Compared with CPAP, the gold standard therapy, OAs are less efficacious but are more accepted and tolerated by patients, which, in turn, may lead to a comparable level of therapeutic effectiveness. Different OA designs currently exist, and more are constantly emerging. Additionally, state-of-the-art technologies are being used in the fabrication of many; however, all the currently available OAs employ the same mechanism of action by targeting the anatomical component involved in the pathogenesis of the disease. Furthermore, the scope of use of OAs is expanding to include patients who are edentulous. For patients with OAs, the dentist is a member of an interdisciplinary team managing OSA, and constant communication and follow-up with the sleep physician and other team members is necessary for disease management.