Multi-center safety and efficacy study of a negative-pressure intraoral device in obstructive sleep apnea.

BACKGROUND: Intraoral devices, with or without negative oral pressure, can stabilize the oropharynx and reduce obstructive sleep apneas. We tested the hypothesis that treatment with the iNAP® Sleep Therapy System, which applies negative oral pressure through an intra-oral appliance, would reduce the severity of obstructive sleep apnea in a multi-center, prospective, first-night-randomized-order cross-over study. METHODS/PATIENTS: 130 patients fulfilled the entry criteria (age <75, AHI 15-55, BMI <33), and 63 entered the primary endpoint cohort (Total Sleep Time ≥4 h/night on the baseline polysomnogram and an oral negative vacuum time maintained by iNAP® ≥ 4 h/night and total sleep time ≥4 h/night during the first treatment study). 54 patients completed a second treatment sleep study at least 28 days after the first sleep study. RESULTS: Among the primary endpoint cohort (n = 63, age = 53.2 ± 11.3, BMI = 27.1 ± 2.8), 33 patients (52 %; 95 % confidence interval = 40%-64 %, p < 0.001) responded to iNAP treatment according to the Sher criteria (>50 % reduction in AHI and an AHI ≤20 events/hr). The average oxy-hemoglobin saturation increased by 1-2%, and the average percent oxygen desaturation decreased (was less severe) by 1 % while using the iNAP device. The incidence of adverse events, all self-limited, was low. The reduction in the apnea-hypopnea index was durable over the 28-day study. Patients used iNAP on average 5.6 h per night during the study period. CONCLUSION: The iNAP® Sleep Therapy System achieved a durable benefit in more than half the patients with moderate to severe obstructive sleep apnea and may be considered in patients who object to or failed continuous positive airway pressure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02698059.

The predictive value of mandibular advancement maneuvers during drug-induced sleep endoscopy for treatment success of oral appliance treatment in obstructive sleep apnea: a prospective study.

STUDY OBJECTIVES: To prospectively validate drug-induced sleep endoscopy with mandibular advancement maneuvers as a prediction tool for treatment success of oral appliance treatment (OAT). METHODS: Seventy-seven patients diagnosed with moderate obstructive sleep apnea were included and underwent drug-induced sleep endoscopy. The upper airway collapse was assessed using the VOTE classification. Additionally, three mandibular advancement maneuvers were performed to predict treatment success of OAT. If the maneuver was negative, the level and degree and configuration of the persistent collapse was described according to the VOTE classification. All patients were treated with OAT and completed a follow-up sleep study with OAT in situ without regard to their anticipated response to treatment. RESULTS: Sixty-four patients completed 6-month follow up. A positive jaw thrust maneuver proved to be significantly associated with favorable OAT response, whereas the chin lift maneuver and the vertical chin lift maneuver were not. Additionally, a persistent lateral oropharyngeal collapse when performing any mandibular advancement maneuver was significantly associated with unfavorable OAT response. CONCLUSIONS: The current findings suggest that a jaw thrust maneuver should be preferred over the chin lift maneuver for predicting OAT response. Patients with a positive jaw thrust maneuver should be counseled toward favorable OAT response, whereas those with persistent lateral oropharyngeal collapse should be advised about the likelihood of unfavorable OAT response. A negative jaw thrust maneuver did not prove to be a significant predictor for unfavorable response to OAT. Consequently, uncertainties arise regarding the justification of performing drug-induced sleep endoscopy solely for predicting the efficacy of OAT. However, the results of the current study could be influenced by heterogeneity in the assessment of respiratory parameters, variability in the performance of the mandibular advancement maneuvers, and the instability of bolus technique sedation. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: Drug-induced Sleep Endoscopy: a prediction tool for success rate of oral appliance treatment; Identifier: NL8425; URL: https://www.onderzoekmetmensen.nl/en/trial/20741. CITATION: Veugen CCAFM, Kant E, Kelder JC, Schipper A, Stokroos RJ, Copper MP. The predictive value of mandibular advancement maneuvers during drug-induced sleep endoscopy for treatment success of oral appliance treatment in obstructive sleep apnea: a prospective study. J Clin Sleep Med. 2024;20(3): 353-361.

Drug-induced Sleep Endoscopy: Are there Predictors for Failure of Oral Appliance Treatment?

Abstract Introduction In the literature, evidence is lacking on the predictive value of druginduced sleep endoscopy (DISE) for oral appliance treatment (OAT). Objectives The aim of the present study is to evaluate whether DISE with concomitant mandibular advancement maneuver can predict failure of OAT. Methods An observational retrospective study including patients diagnosed with obstructive sleep apnea (OSA) who previously received OAT. Results of DISE were analyzed in a group with documented OAT failure (apnea-hypopnea index [AHI] >10 events/hour or < 50% reduction) and a group with OAT benefit (AHI <10 events/hour or >50% reduction). The upper airway was assessed using the velum, oropharynx, tongue base, epiglottis (VOTE) classification. Additionally, a mandibular advancement maneuver, manually protruding the mandible by performing a jaw thrust, was performed to mimic the effect of OAT. Results The present study included 50 patients with OAT failure and 20 patients with OAT benefit. A subgroup analysis of patients with OAT failure and an AHI <30events/hour included 26 patients. In the OAT failure group, 74% had a negative jaw thrust maneuver. In the subgroup with an AHI <30 events/hour, 76.9% had a negative jaw thrust maneuver. In the OAT benefit group, 25% had a negative jaw thrust maneuver (p< 0.001). Conclusions A negative jaw thrust maneuver during DISE can be a valuable predictor for OAT failure, independent of AHI. Drug-induced sleep endoscopy should be considered as a diagnostic evaluation tool before starting OAT.

Drug-induced Sleep Endoscopy: Are there Predictors for Failure of Oral Appliance Treatment?

Introduction In the literature, evidence is lacking on the predictive value of drug-induced sleep endoscopy (DISE) for oral appliance treatment (OAT). Objectives The aim of the present study is to evaluate whether DISE with concomitant mandibular advancement maneuver can predict failure of OAT. Methods An observational retrospective study including patients diagnosed with obstructive sleep apnea (OSA) who previously received OAT. Results of DISE were analyzed in a group with documented OAT failure (apnea-hypopnea index [AHI] > 10 events/hour or < 50% reduction) and a group with OAT benefit (AHI <10 events/hour or > 50% reduction). The upper airway was assessed using the velum, oropharynx, tongue base, epiglottis (VOTE) classification. Additionally, a mandibular advancement maneuver, manually protruding the mandible by performing a jaw thrust, was performed to mimic the effect of OAT. Results The present study included 50 patients with OAT failure and 20 patients with OAT benefit. A subgroup analysis of patients with OAT failure and an AHI < 30 events/hour included 26 patients. In the OAT failure group, 74% had a negative jaw thrust maneuver. In the subgroup with an AHI < 30 events/hour, 76.9% had a negative jaw thrust maneuver. In the OAT benefit group, 25% had a negative jaw thrust maneuver ( p < 0.001). Conclusions A negative jaw thrust maneuver during DISE can be a valuable predictor for OAT failure, independent of AHI. Drug-induced sleep endoscopy should be considered as a diagnostic evaluation tool before starting OAT.