The Ultra-Long-Term Sleep study: Design, rationale, data stability and user perspective.

Sleep deprivation and poor sleep quality are significant societal challenges that negatively impact individuals' health. The interaction between subjective sleep quality, objective sleep measures, physical and cognitive performance, and their day-to-day variations remains poorly understood. Our year-long study of 20 healthy individuals, using subcutaneous electroencephalography, aimed to elucidate these interactions, assessing data stability and participant satisfaction, usability, well-being and adherence. In the study, 25 participants were fitted with a minimally invasive subcutaneous electroencephalography lead, with 20 completing the year of subcutaneous electroencephalography recording. Signal stability was measured using covariance of variation. Participant satisfaction, usability and well-being were measured with questionnaires: Perceived Ease of Use questionnaire, System Usability Scale, Headache questionnaire, Major Depression Inventory, World Health Organization 5-item Well-Being Index, and interviews. The subcutaneous electroencephalography signals remained stable for the entire year, with an average participant adherence rate of 91%. Participants rated their satisfaction with the subcutaneous electroencephalography device as easy to use with minimal or no discomfort. The System Usability Scale score was high at 86.3 ± 10.1, and interviews highlighted that participants understood how to use the subcutaneous electroencephalography device and described a period of acclimatization to sleeping with the device. This study provides compelling evidence for the feasibility of longitudinal sleep monitoring during everyday life utilizing subcutaneous electroencephalography in healthy subjects, showcasing excellent signal stability, adherence and user experience. The amassed subcutaneous electroencephalography data constitutes the largest dataset of its kind, and is poised to significantly advance our understanding of day-to-day variations in normal sleep and provide key insights into subjective and objective sleep quality.

Self-reported dizziness, falls, and self-rated health in a rural population in Denmark.

PURPOSE: To investigate associations between dizziness, hearing loss, medication, and self-perceived health in the region of Lolland-Falster in Denmark. METHODS: A cross-sectional population-based study using data from questionnaires and physical examinations between February 8th, 2016, and February 13th, 2020. Individuals aged 50 years or above in the region of Lolland-Falster were randomly invited to participate. RESULTS: Of 10,092 individuals (52% female), the mean age was 64.7 and 65.7 years for females and males, respectively. 20% reported dizziness during the past 30 days, and prevalence increased with age. 24% of dizzy females suffered from falls compared to 21% of males. 43% sought treatment for dizziness. Logistic regression revealed a higher odds ratio of dizziness in groups with poor self-perceived health (OR = 2.15, 95% CI [1.71, 2.72]) and very poor self-perceived health (OR = 3.62 [1.75, 7.93]) compared to moderate self-perceived health. A higher OR was found for seeking treatment for dizziness in the group that had experienced falls (OR = 3.21 [2.54, 4.07]). 40% reported hearing loss. Logistic regression revealed a higher OR for dizziness in the group with severe hearing loss (OR = 2.40 [1.77, 3.26]) and moderate hearing loss (OR = 1.63 [1.37, 1.94]) compared to no hearing loss. CONCLUSION: One of five participants reported dizziness during the last month. Dizziness was negatively associated with self-perception of good health also after adjusting for comorbidities. Almost half of the dizzy participants sought treatment for dizziness and 21% experienced falls. Identification and treatment of dizziness are important to prevent falls from happening. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov (NCT02482896).

Transmyringeal ventilation tube insertion for unilateral Menière's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial.

BACKGROUND: Menière's disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, the patient is usually severely incapacitated. Currently, there is no consensus on the treatment of Menière's disease. The evidence regarding most treatment options is sparse due to a lack of randomized trials together with an often-spontaneous relief over time and a considerable placebo effect. Insertion of a transmyringeal tube is a simple and relatively safe, minimally invasive procedure and previous open-label trials have shown promising results. STUDY DESIGN: This is a prospective, sham-controlled, double-blinded, randomized, clinical trial. AIM: This trial aims to assess the effects of inserting a ventilation tube into the tympanic membrane compared with sham treatment for definite or probable unilateral Menière's disease according to the criteria formulated by the Classification Committee of the Bàràny Society. OUTCOMES: The primary outcome will be the number of spontaneous vertigo attacks lasting more than 20 min and time to treatment failure. In addition to the primary outcome, we will assess various secondary outcomes related to hearing, ear fullness, dizziness, and serious adverse events. SAMPLE SIZE: An estimated 104 participants in total or 52 participants in each group will be necessary. The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025. TRIAL STATUS: ClinicalTrials.gov : NCT04835688 . Registered on April 8, 2021. PROTOCOL VERSION: 1.8, 26-09-2022. Date of first enrollment: October 1st, 2021. End of study: anticipated January 2025.

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Abstract Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence. Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19-1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence.

Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence. Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19-1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

[Episodic vestibular syndrome].

Dizziness and vertigo are frequent symptoms in the primary care facility and emergency departments. Episodic vestibular syndrome (EVS) is defined as episodic dizziness, vertigo or postural imbalance with remission between episodes. EVS can be divided into spontaneous (s-EVS) and triggered EVS (t-EVS). Causes of s-EVS are vestibular migraine, Menière's disease, transient ischaemic attack and vestibular paroxysmia. Causes of t-EVS are benign paroxysmal positionel vertigo, orthostatic hypotension and panick attacks. In this review, we recommend using vestibular syndromes in order to reduce the number of differential diagnoses.

[The chronically dizzy patient].

Many medical, neurologic and psychiatric conditions as well as drugs can give chronic dizziness, and a systematic diagnostic workup is essential. Chronic vestibular syndrome is a clinical syndrome of chronic vertigo, dizziness or unsteadiness lasting months to years. There is generally a persistent unilateral or bilateral vestibular loss. Treatment depends on the aetiology, but in general, treatment with vestibular rehabilitation is effective, which is summarised in this review. Betahistin or other anti-vertigo-drugs are not indicated in the treatment of chronic vertigo.

[MRI for middle-ear cholesteatoma diagnostics].

Non-echoplanar diffusion-weighted magnetic resonance imaging (non-EPI-DWMRI) for depicting middle-ear cholesteatoma has a sensitivity as well as specificity at around 90%. It is the accumulated keratin, which results in a high-intensity signal. The detection limit is 3 mm. When applying non-EPI-DWMRI as part of post-operative follow-up, first scan is recommended around one year post-operatively followed by annual scans, until a possible recidive is expected to have reached the detection limit. In children, a closer follow-up is suggested, as paediatric cholesteatomas are more aggressive.

[Superior semicircular canal dehiscence syndrome].

Superior semicircular canal dehiscence syndrome (SCDS) is caused by a bony defect of the superior semicircular canal. The bony defect allows low-frequency acoustic stimuli of high intensity to travel to the vestibular organ. This can be induced by sound stimuli or pressure stimuli leading to vertigo, torsional nystagmus, pulsatile tinnitus, hyperacusis, hearing loss and autophony. SCDS is diagnosed with provocative testing, audiometry, CT-scan, vestibular evoked myogenic potentials and electrocochleography. Treatment is conservative, however, surgery with occlusion of the defect can be necessary for debilitating symptoms, as argued in this review.

[Perilymphatic fistula occurring spontaneously after cholesteatoma surgery].

This case report describes a 53-year-old woman, who presented with symptoms of a perilymphatic fistula (PLF), developed 12 years after most recent surgery. The diagnosis was confirmed by a combination of clinical observations, temporal computed tomography, audiometry and video head impulse test. PLF normally occurs after traumatic lesions or substantial infections of the middle ear, often including cholesteatomas, and should be suspected when patients with the relevant clinical history present with sudden onset of unilateral hearing loss, dizziness, tinnitus and aural fullness.

No impact on the incidence rate of adenoidectomy 1998-2014 on a national level in Denmark by the use of nasal steroid and the introduction of pneumococcal vaccines.

OBJECTIVE: To describe trends in incidence rates of adenoidectomy in children in Denmark from 1998-2014 and to look for possible explanatory factors such as intranasal steroids and pneumococcal vaccination. DESIGN: A nationwide, population-based, retrospective, interrupted time-series analysis, using data from Danish registries. SETTING: Hospitals and private Ear, Nose and Throat clinics. PARTICIPANTS: Children who underwent adenoidectomy from 1998 to 2014 in Denmark. MAIN OUTCOME MEASURE: Adenoidectomy. METHODS: The National Patient Register and the National Health insurance Service Register were used to identify all adenoidectomies performed in children. The National Prescription Register supplied data on intranasal steroids. RESULTS: A total of 174,557 adenoidectomies were identified, distributed among 153 022 children. The annual incidence rate was stable at around 11 per 1000 person-years from 1998 to 2004. A decrease was seen from 2004 reaching 7.9 in 2009, followed by an increase to 9.1 in 2014. The highest age-specific incidence rates were seen at 2-3 years of age. An estimated 14% of children born in 2014 will have had adenoidectomy performed before turning 16 years old. The proportion of adenoidectomies performed in private clinics compared with hospitals was 90%. CONCLUSION: From 1998 to 2004 the incidence rate of adenoidectomy in children in Denmark was among the highest in the world with around 11 per 1000 person-years. A decrease to 7.9 was seen from 2004 to 2009. We found no inverse correlation on a national level between the incidence rates of adenoidectomy and intranasal steroid, nor the introduction of the pneumococcal vaccine. The amount of intranasal steroids used in children in Denmark was negligible compared with adenoidectomy.

[HINTS for diagnosing acute dizzy patients].

Acute vestibular syndrome (AVS) is an acute-onset of continuous vertigo with no other neurological deficits. AVS is most often of peripheral origin - vestibular organ or nerve. However, in some cases AVS is caused by a posterior circulation stroke (PCS). Head impulse, nystagmus and test of skew (HINTS) can be used to differentiate peripheral causes of AVS from central causes. Within the first 48 hours after onset of symptoms, HINTS has a higher sensitivity of detecting PCS (96-100%) than an MRI (72-87%). We recommend using HINTS for acute dizzy patients.

Current state of evidence for endolymphatic sac surgery in Menière's disease: a systematic review.

Background: Endolymphatic sac surgery is an invasive procedure recommended to patients with Menière's disease. Aims/Objectives: To provide an overview and quality assessment of the existing evidence and to provide an updated assessment of the utility of endolymphatic sac surgery in Menière's disease. Material and Methods: We performed a systematic literature search for systematic reviews and randomized controlled trials (RCTs). The AMSTAR tool was used to assess the quality of systematic reviews and the Cochrane risk of bias tool for RCTs. The overall certainty of effects for the individual outcomes was evaluated using the GRADE approach. Results: One systematic review of high quality matched the inclusion criteria, and included three RCTs. An updated literature search from the last search date of the included review provided no further relevant RCTs. The identified RCTs individually reported a positive effect of both the placebo and active treatment groups following surgery, strongly indicative of a placebo effect. The overall certainty of the effect was very low. Conclusions and significance: There is still a lack of high-quality research suggesting that endolymphatic sac surgery provides a significant amount of symptomatic relief for Menière's patients.

Intratympanic Steroid for Menière's Disease: A Systematic Review.

OBJECTIVES: To investigate the beneficial effects and safety of intratympanic steroid installation compared with placebo in patients with Menière's disease. METHODS: We performed a systematic literature search in MEDLINE and EMBASE for existing systematic reviews and individual randomized controlled trials (RCTs). Studies were included if they investigated the usage intratympanic steroids in patients aged 18 and above, with definite or probable Menière's disease. The quality of the identified existing reviews was assessed using the AMSTAR tool. The risk of bias in RCTs was assessed using the Cochrane Risk of Bias Tool and overall quality of the individual outcomes was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method. RESULTS: The literature search provided four systematic reviews, from which one yielded a sufficient AMSTAR evaluation and subsequently provided three RCTs relevant for inclusion. Due to the lack of sufficient reporting of the data, quantitative synthesis was not applicable. In the qualitative synthesis for the primary outcome, the results from the RCTs showed that there was a slight indication of steroid treatment reducing the frequency of vertiginous attacks. No serious adverse events were reported. Based on the GRADE approach the quality for both findings is very low. No studies reported on the secondary outcomes. CONCLUSION: The effect of intratympanic steroid treatment in Menière's disease is questionable. There is a great need for further research to sufficiently assess whether steroid treatment may be considered as a safe and effective treatment for patients with Menière's disease.

[Bilateral vestibulopathy after intravenous gentamicin therapy].

This case report is about a 70-year-old man, who developed bilateral vestibulopathy due to intravenous gentamicin for endocarditis, and during admission he developed dizziness and oscillopsia. He was diagnosed with bilateral vestibulop-athy, when saccades were found on a video head impulse test (vHIT). The diagnosis was postponed by the lack of severe vertigo and nystagmus, which is seen in acute unilateral vestibulopathy. When gentamicin-induced vestibulapathy is suspected, a vHIT examination is recommended.

Positive pressure device treatment for Menière's disease: an overview of the current evidence and a meta-analysis.

OBJECTIVE: The objective was to critically assess the current evidence investigating the efficacy of using a positive pressure device in patients with definite or probable Menière's disease. METHODS: We performed a systematic literature search in MEDLINE, EMBASE and PsycINFO up to February 2018. We included both systematic reviews and primary literature [randomized controlled trials (RCTs)] investigating positive pressure treatment, in patients (≥ 18 years of age), with Menière's disease. We assessed the internal validity of systematic reviews using the AMSTAR tool and risk of bias of primary studies using the Cochrane Risk of bias tool. We performed a meta-analysis for each outcome based on the identified studies. The overall certainty of evidence for the outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: The search for systematic reviews identified four relevant reviews. These all included the same four RCTs. An updated search identified one additional RCT. In total, five RCTs were included in the data synthesis. Our data synthesis showed no effect of positive pressure treatment on primary nor secondary outcomes. No serious adverse events were reported. The overall certainty of evidence ranged from very low to low, due to the serious risk of bias and imprecision. CONCLUSION: The current available evidence does not support positive pressure device treatment in patients with Menière's disease. However, the limitations of the current literature hinder the possibility of any solid conclusion. There remains a need for randomized controlled trials of high quality to fully access the utility of this treatment.

Incidence and prevalence of sporadic and hereditary MTC in Denmark 1960-2014: a nationwide study.

Recent studies have shown a significant increase in the temporal trend of medullary thyroid carcinoma (MTC) incidence. However, it remains unknown to which extent sporadic medullary thyroid carcinoma (SMTC) and hereditary MTC (HMTC) affect the MTC incidence over time. We conducted a nationwide retrospective study using previously described RET and MTC cohorts combined with review of medical records, pedigree comparison and relevant nationwide registries. The study included 474 MTC patients diagnosed in Denmark between 1960 and 2014. In the nationwide period from 1997 to 2014, we recorded a mean age-standardized incidence of all MTC, SMTC and HMTC of 0.19, 0.13 and 0.06 per 100,000 per year, respectively. The average annual percentage change in incidence for all MTC, SMTC and HMTC were 1.0 (P = 0.542), 2.8 (P = 0.125) and -3.1 (P = 0.324), respectively. The corresponding figures for point prevalence at January 1, 2015 were 3.8, 2.5 and 1.3 per 100,000, respectively. The average annual percentage change in prevalence from 1998 to 2015 for all MTC, SMTC and HMTC was 2.8 (P < 0.001), 3.8 (P < 0.001) and 1.5 (P = 0.010), respectively. We found no significant change in the incidence of all MTC, SMTC and HMTC possibly due to our small sample size. However, due to an increasing trend in the incidence of all MTC and opposing trends of SMTC (increasing) and HMTC (decreasing) incidence, it seems plausible that an increase for all MTC seen by others may be driven by the SMTC group rather than the HMTC group.

A nationwide study on the impact of pneumococcal conjugate vaccination on antibiotic use and ventilation tube insertion in Denmark 2000-2014.

Introduction of Pneumococcal Conjugated Vaccines (PCV) in national immunization programs have been successful in reducing the number of invasive and lower respiratory pneumococcal infections. The impact of the vaccines on upper respiratory infections caused by pneumococci is less clear although these account for most pneumococcal infections. In this study, we used likely proxies for respiratory infections in children, such as antibiotic use and ventilation tube insertions (VTI), to estimate the impact of the vaccine on a national level. The study was designed as a population-based retrospective observational study, comparing trends in the incidence rate of antibiotic prescriptions and VTIs in the period 2000-2014, where PCV7 was introduced in 2007 and PCV13 in 2010. The introduction of PCV7 and PCV13 correlated with changes in the incidence rate from an almost steady increase in prescription of antibiotics in the pre-PCV period to a decreasing incidence for all children age 0-15years. The 2.4 DDD per person year in 2014 was at almost the same level of antibiotic use as in 2000 at 2.3 DDD per person year. Similar patterns were observed in the mostly vaccinated age groups below 5years of age. For VTI we observed a decreasing incidence rate in the years following introduction of PCV13 ending with a slightly higher incidence at 35 per 1000 person years in 2014 compared to 31 in year 2000. We conclude that the steady increase in antibiotic use and VTI in the pre-PCV period have been partially reversed to near year 2000 levels after the introduction of PCV. This indicates that implementation of pneumococcal vaccines in the Childhood Vaccination Programme has likely reduced the incidence of upper respiratory diseases due to pneumococci in Denmark.

The impact of ventilation tubes in otitis media on the risk of cholesteatoma on a national level.

OBJECTIVE: To estimate the impact of treatment with middle ear ventilation tube insertion (VTI) in children with otitis media (OM) on the risk of cholesteatoma on a national level. METHODS: Data were obtained from the Danish National Patient Register, the National Health Service Register and Statistics Denmark. Cumulative incidence proportions were estimated by the Kaplan-Meier method and hazard ratios with Cox regression analysis. The first surgically treated middle ear cholesteatoma in a child (STMEC1) was considered an event. RESULTS: A total of 217,206 children, born after December 31, 1996, who had VTI from January 1, 1997 to August 31, 2011 were identified. Of these, 374 subsequently had a STMEC1. A corresponding 36,981 children without any VTI were identified for comparison using a random 5% sample of the Danish population. Of these, 5 had a STMEC1. The cumulative incidence proportion with STMEC1 at 12 years of age for children with 0, 1, 2, 3, and ≥4 VTI's was 0.04% (95% confidence interval 0.02-0.12%), 0.21% (0.18-0.26%), 0.35% (0.28-0.43%), 0.40% (0.30-0.54%), and 0.55% (0.44-0.70%), respectively. In the regression model each additional year of age before the first VTI increased the risk of STMEC1 by 54% (47-63%), while each additional year between two successive tube insertions increased the risk by 28% (15-43%). CONCLUSION: We found that prolonged OM requiring multiple VTIs was associated with an increased risk of STMEC1. Early age at first VTI and short time between two VTIs was associated with a lower risk of STMEC1. This may be the result of reduced time with negative middle ear pressure and OM. However, these findings may be susceptible to selection bias, as age at first VTI and time between VTIs, as well as the outcome variable, STMEC1, may all depend on the underlying indication for VTI. In short the present study suggests that treatment with VTI in children with OM reduces the risk of STMEC1 on a population level. However, for the individual child the absolute risk reduction is very small, and the decision of treatment with VTI must always rely on the symptoms and clinical findings in the individual child.