High Definition transcranial Direct Current Stimulation (HD-tDCS) for chronic tinnitus: Outcomes from a prospective longitudinal large cohort study.

BACKGROUND: Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-tDCS). OBJECTIVE: Investigation of the effect of HD-tDCS on tinnitus in a large patient cohort. METHODS: This prospective study included 117 patients with chronic, subjective, non-pulsatile tinnitus who received six sessions of anodal HD-tDCS of the right Dorsolateral Prefrontal Cortex (DLPFC). Therapy effects were assessed by use of a set of standardized tinnitus questionnaires filled out at the pre-therapy (Tpre), post-therapy (T3w) and follow-up visit (T10w). Besides collecting the questionnaire data, the perceived effect (i.e., self-report) was also documented at T10w. RESULTS: The Tinnitus Functional Index (TFI) and Tinnitus Questionnaire (TQ) total scores improved significantly over time (pTFI<0.01; pTQ<0.01), with the following significant post hoc comparisons: Tpre vs. T10w (pTFI<0.05; pTQ<0.05) and T3w vs. T10w (pTFI<0.01; pTQ<0.01). The percentage of patients reporting an improvement of their tinnitus at T10w was 47%. Further analysis revealed a significant effect of gender with female patients showing a larger improvement on the TFI and TQ (pTFI<0.01; pTQ<0.05). CONCLUSIONS: The current study reported the effects of HD-tDCS in a large tinnitus population. HD-tDCS of the right DLPFC resulted in a significant improvement of the tinnitus perception, with a larger improvement for the female tinnitus patients.

Correction to: Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

Following publication of the original article [1], the authors reported that Fig. 1 had not been corrected based on the reviewer's comments. The correct Fig. 1 is presented below.

Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

BACKGROUND: The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported. METHODS: This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies. DISCUSSION: Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.

An Exploratory Study on the Use of Event-Related Potentials as an Objective Measure of Auditory Processing and Therapy Effect in Patients With Tinnitus: A Transcranial Direct Current Stimulation Study.

OBJECTIVE: Treatment effect in tinnitus research is commonly evaluated by use of self-report questionnaires. As this is a solely subjective assessment method, the need for an objective measurement is paramount to genuinely evaluate the effects of therapeutic interventions. The current study explores the value of event-related potentials (ERPs) in the evaluation of high-definition transcranial direct current stimulation (HD-tDCS) for tinnitus treatment. STUDY DESIGN: Prospective exploratory study. SETTING: Tertiary referral center. PATIENTS: Twenty-two chronic tinnitus patients. INTERVENTION: HD-tDCS. MAIN OUTCOME MEASURES: ERPs. RESULTS: The results show a significant shortening of the N1, P2, N2, and P3 latencies after HD-tDCS treatment. Moreover, the increased amplitude of the P2 and N2 peaks result in more salient and clear peaks, with the amplitude of N2 being significant larger after HD-tDCS. However, the ERP changes are not significantly correlated with the change in tinnitus functional index (TFI) total score. CONCLUSIONS: The current study was the first to explore ERPs as objective measure in a study with HD-tDCS in tinnitus patients. Adding ERPs to the outcome measures in tinnitus research may lead to a better understanding of the therapeutic effect in the future. The results showed a shortening of ERP latencies and an increased N2 amplitude, possibly reflecting more effective sound processing with higher recruitment of synchronized neurons in the auditory cortex. Future studies should elaborate on these results, by collecting control data and adding a sham group, to provide a better insight in the underlying mechanism of the ERP changes after tinnitus treatment.

Perioperative Care of Patients With Obstructive Sleep Apnea Undergoing Upper Airway Surgery: A Review and Consensus Recommendations.

IMPORTANCE: To date, no consensus exists regarding optimal perioperative care of patients with obstructive sleep apnea (OSA) undergoing upper airway (UA) surgery. These patients are at risk related to anesthesia and postoperative analgesia, among other risks associated with difficult airway control, and may require intensified perioperative management. OBJECTIVE: To provide a consensus-based guideline by reviewing available literature and collecting expert opinion during an international consensus meeting with experts from relevant speciliaties. EVIDENCE REVIEW: In a consensus meeting conducted on April 4, 2018, a total of 47 questions covering preoperative, intraoperative, and postoperative care were formulated by 12 international experts with extensive clinical experience in the field of UA surgery for OSA. Systematic literature searches were performed by an independent information specialist and 6 researchers according to the Oxford and GRADE systems, and 164 articles published on or before December 31, 2011, were included in the analysis. Two moderators chaired the meeting according to the Amsterdam Delphi Method, including iteration of literature conclusions, expert discussion, and voting rounds. Consensus was reached when there was 70% or more agreement among experts. FINDINGS: Of 47 questions, 35 led to a recommendation or statement. The remaining 12 questions provided no additional information and were excluded in the judgment of experts. Consensus was reached for 32 recommendations. For 1 question there was less than 70% agreement among experts; therefore, consensus was not achieved. Highlights of these recommendations include (1) postoperative bleeding is a complication described for all types of UA surgery; (2) OSA is a relative risk factor for difficult mask ventilation and intubation, and plans for difficult airway management should be considered and implemented; (3) safe perioperative care should be provided, with aspects such as OSA severity, adherent use of positive airway pressure, type of surgery, and comorbidities taken into account; (4) although there is no direct evidence to date, in patients undergoing UA surgery, preoperative treatment with positive airway pressure may reduce the risk of postoperative airway complications; and (5) alternative pain management options perioperatively to reduce opioid use should be considered. CONCLUSIONS AND RELEVANCE: This consensus contains 35 recommendations and statements on the perioperative care of patients with OSA undergoing UA surgery and may be used as a guideline in daily practice.

Treatment of sleep-disordered breathing with positional therapy: long-term results.

PURPOSE: The aim of the present study was to assess the efficacy of a sleep position trainer (SPT) in patients with an established diagnosis of positional obstructive sleep apnea and to evaluate the adherence after 1-year follow-up. METHODS: Polysomnography (PSG) was performed at baseline and after 1 year of SPT use. Patients received questionnaires to assess treatment satisfaction and subjective adherence. Data on objective adherence and number of vibrations initiated by the SPT were collected from the SPT device. RESULTS: Nine out of 58 patients stopped using the SPT during the first year of treatment (16%). Thirty-four middle-aged and overweight patients underwent a PSG after 1 year of SPT use (male/female ratio, 28/6; overall apnea/hypopnea index (AHI), 16/h). A significant reduction in overall AHI to 6/h was observed using treatment (p < 0.001). The median percentage of supine sleep decreased significantly to 1% with SPT (p < 0.001). The mean objective SPT use in 28 patients was 7.3 ± 0.9 h/night and 69 ± 26% of the nights. Furthermore, 75% of the patients reported a better sleep quality since the start of SPT treatment. CONCLUSIONS: Long-term treatment with the SPT was found to be effective in reducing overall AHI. Time spent sleeping in supine position was reduced to almost zero in the continuing users. Patient satisfaction was high when using the SPT.

Successful upper airway stimulation therapy in an adult Down syndrome patient with severe obstructive sleep apnea.

PURPOSE: The aim of this study was to report on the successful application of upper airway stimulation (UAS) therapy in an adult Down syndrome (DS) patient with severe obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) intolerance. METHODS: Baseline polysomnography (PSG) in a 23-year-old male OSA patient (body mass index (BMI) 24.4 kg/m2) revealed an apnea/hypopnea index (AHI) of 61.5 events/h and oxygen desaturation index (ODI) of 39.7 events/h. Based on the clinical examination, PSG and drug-induced sleep endoscopy, the patient fulfilled the formal inclusion criteria for UAS therapy: AHI between 15 and 65 events/h, BMI < 32 kg/m2, and no complete concentric collapse at the level of the velopharynx. RESULTS: Implantation of the hypoglossal nerve stimulator in the adult patient with DS resulted in a substantial subjective as well as objective improvement of OSA (63 to 81% decrease in AHI and 77% decrease in ODI), translating into an overall satisfactory outcome. CONCLUSION: Research on the long-term effectiveness of UAS therapy in a larger group of patients with DS is needed. However, based on the available literature and our presented case, respiration-synchronized electrostimulation of the hypoglossal nerve using UAS therapy may have a potential value in well-selected OSA patients with DS who are non-compliant to CPAP therapy.

Effects of Electrical Stimulation in Tinnitus Patients: Conventional Versus High-Definition tDCS.

BACKGROUND: Contradictory results have been reported for transcranial direct current stimulation (tDCS) as treatment for tinnitus. The recently developed high-definition tDCS (HD tDCS) uses smaller electrodes to limit the excitation to the desired brain areas. OBJECTIVE: The current study consisted of a retrospective part and a prospective part, aiming to compare 2 tDCS electrode placements and to explore effects of HD tDCS by matched pairs analyses. METHODS: Two groups of 39 patients received tDCS of the dorsolateral prefrontal cortex (DLPFC) or tDCS of the right supraorbital-left temporal area (RSO-LTA). Therapeutic effects were assessed with the tinnitus functional index (TFI), a visual analogue scale (VAS) for tinnitus loudness, and the hyperacusis questionnaire (HQ) filled out at 3 visits: pretherapy, posttherapy, and follow-up. With a new group of patients and in a similar way, the effects of HD tDCS of the right DLPFC were assessed, with the tinnitus questionnaire (TQ) and the hospital anxiety and depression scale (HADS) added. RESULTS: TFI total scores improved significantly after both tDCS and HD tDCS (DLPFC: P < .01; RSO-LTA: P < .01; HD tDCS: P = .05). In 32% of the patients, we observed a clinically significant improvement in TFI. The 2 tDCS groups and the HD tDCS group showed no differences on the evolution of outcomes over time (TFI: P = .16; HQ: P = .85; VAS: P = .20). CONCLUSIONS: TDCS and HD tDCS resulted in a clinically significant improvement in TFI in 32% of the patients, with the 3 stimulation positions having similar results. Future research should focus on long-term effects of electrical stimulation.

Evaluation of a Trial Period With a Sleep Position Trainer in Patients With Positional Sleep Apnea.

STUDY OBJECTIVES: To assess the overall clinical effectiveness of a sleep position trainer (SPT) in patients with positional obstructive sleep apnea (POSA) and to evaluate how many patients were willing to continue treatment after a 1-month trial period. METHODS: Patients in whom POSA was diagnosed underwent a 1-month trial period with the SPT. Home sleep apnea tests were used to measure baseline data and data following the trial period with the SPT. RESULTS: The 79 patients who completed the study protocol were 81% male, had a mean age of 52 ± 12 years, and a median baseline respiratory event index (REI) of 11 (8, 16) events/h. A significant reduction in overall REI to 5 (3, 10) events/h was observed with the SPT as compared to baseline (P < .001). The median percentage of sleep time in the supine position decreased significantly from 27 (20, 48) to 7 (2, 20) with the SPT (P < .001). Adherence was found to be 95 ± 8%. Of the 44 patients who decided to continue treatment, 27 were categorized as responders (having a decrease in REI of at least 50%) and 17 were non-responders. The most important reasons for not purchasing the SPT were poor objective results, intolerance to the vibrations, cost of the device, persistent daytime sleepiness, or patient preference for other treatment options. CONCLUSIONS: Treatment with the SPT came with high adherence rates and was effective in reducing REI and supine sleep position. The trial period is in the patients' best interest, as it may prevent those who will not benefit from positional training from purchasing an SPT.

The use of drug-induced sleep endoscopy in England and Belgium.

PURPOSE: The purpose of this international survey is to ascertain the current practice of drug-induced sleep endoscopy (DISE) for patients with sleep-disordered breathing (SDB) by Otolaryngologists in the United Kingdom and Belgium. We compare the results with recommendations from the European Position Paper on drug-induced sleep endoscopy. METHODS: An online questionnaire was circulated to Consultant Otolaryngologists, independent practitioners, and trainees across the two countries. Eleven questions were used in total. RESULTS: 181 responses from the UK and 117 responses from Belgium were received, mostly from consultants and independent practitioners. SDB was a common presentation to ENT practice, seen by over 90% of clinicians. The use of DISE varied greatly between the two countries (72.9% Belgium, 26.1% UK). 54.1% of Belgian respondents use DISE on over 50% of their patients, compared to only 32.4% of British clinicians. Attitudes of surgeons towards the diagnostic value of DISE varied; in Belgium, the majority (54%) gave a rating of 3 or more (1 = useless to 5 = essential), with no respondents giving a score of 0 (useless). In the UK only 16% of respondents felt DISE had useful clinical value, with 25 respondents deeming it 'useless'. The majority opt for DISE when non-surgical therapies fail (51.4% UK, 61.3% Belgium). The majority of participants do not use objective measures for depth of sedation (75.7% UK, 66.7% Belgium), with a marked variation on anaesthetic methods. 62.2% of UK clinicians do not use a classification system, whereas in Belgium the majority of clinicians (60.8%) use the VOTE grading system. CONCLUSIONS: Clinicians in Belgium were more favourable to using DISE than in the UK. Differences in its clinical effectiveness were apparent between the two countries. A consensus on patient selection, method of sedation and an effective classification system seemed to be lacking from both countries. Further education is required to raise awareness for the use of DISE.

Development of a Clinical Pathway and Technical Aspects of Upper Airway Stimulation Therapy for Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA) is a common disease with high morbidity and related mortality. Narrowing and collapse of the pharyngeal airway during sleep characterize the disease, resulting in a decrease (hypopnea) or a complete cessation (apnea) of oronasal airflow. Upper airway stimulation (UAS), using electrical neurostimulation of the hypoglossal nerve (n. XII) synchronized with ventilation, is a novel, evolving treatment option. UAS was found to be an effective treatment in CPAP-intolerant patients. The treatment success is partly due to the strict selection of the patients, based on previous findings. Furthermore, post-operative follow-up is needed in order to maintain or improve treatment outcome. Therefore, a clinical pathway, which provides structure and standardization, is crucial. In this paper, the aim is to discuss the technical aspects of UAS therapy and to describe a clinical pathway to organize the care process of UAS for OSA in a structured and standardized way.