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.

Minimally invasive surgery for placement of a subcutaneous EEG implant.

Background: A new class of subcutaneous electroencephalography has enabled ultra long-term monitoring of people with epilepsy. The objective of this paper is to describe surgeons' experiences in an early series of implantations as well as discomfort or complications experienced by the participants. Methods: We included 38 implantation procedures from two trials on people with epilepsy and healthy adults. Questionnaires to assess surgeons' and participants' experience were analyzed as well as all recorded adverse events occurring up to 21 days post-surgery. Results: With training, the implantation could be performed in approximately 15 min. Overall, the implantation procedure was considered easy to perform with only 2 episodes where the implant got fixated in the introducing needle and a new implant had to be used. The explantation procedure was considered effortless. In 2 cases the silicone sheath covering the lead was damaged during the explantation, but it was possible to remove the entire implant without leaving any foreign body under the skin. Especially in the trial on healthy participants, a proportion experienced adverse events in the form of headache or implant-pain up to 21 days post-operatively. In 6 cases, adverse events contributed to the decision to explant and discontinue the study: Four of these cases involved implant pain or headache; One case involved a post-operative local infection; and in one case superficial lead placement resulted in skin perforation a few weeks after implantation. Conclusion: The implantation and explantation procedures are considered swift and easy to perform by both neurosurgeons and ENT surgeons. The implant is well tolerated by most participants. However, headache or pain around the implant can occur for up to 21 days post-operatively as anticipated with any such surgery. The expected benefits from the implant should always outweigh the potential disadvantages.

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.

Hearing and Disease-Specific Health-Related Quality of Life in Patients with Otosclerosis after Stapedotomy - a Trial of the SPOT-25 Questionnaire.

BACKGROUND: The study aims to investigate the effect of stapedotomy on audiology measurements and the disease-specific health-related quality of life for patients with otosclerosis using the Danish Stapesplasty Outcome Test-25 as a quality of life measuring tool. METHODS: In this study, 50 patients who had undergone stapedotomy at our department between September 2017 and December 2020 were included. Data collection was performed by audiometric testing (pure tone and speech audiometry) in the pre- and postoperative settings. Health-related quality of life was assessed pre- and postoperatively in 30 patients using the validated Danish Stapesplasty Outcome Test-25. RESULTS: The mean improvement in air conduction thresholds was 27.7 dB and the mean improvement in air-bone gap was 21.8 dB. Health- related quality of life improved significantly after stapes surgery in all subscores of the Stapesplasty Outcome Test-25 (hearing, mental condition, social restriction, and general), except for "tinnitus." The improvement in the audiometric data correlated significantly with the improvement in "total score" and "hearing function" but not with "tinnitus," "social restrictions," and "mental condition." CONCLUSION: Stapedotomy leads to significant improvement in hearing and health-related quality of life. The Stapesplasty Outcome Test-25 can be used as a valuable supplement to the hearing test by assessing health-related quality of life.

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.

[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.

[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.

[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.

Validity and Test-Retest Reliability of the translated Stapesplasty Outcome Test 25 for Measurement of Disease-Specific Quality of Life in Patients with Otosclerosis.

OBJECTIVES: To assess the validity and test-retest reliability of the Danish Stapesplasty Outcome Test 25 (SPOT-25) version. MATERIALS AND METHODS: The German SPOT-25 questionnaire-consisting of 25 questions within the subscores "hearing function," "tinnitus," "mental condition," "social restrictions," and "general quality of life," found to be significant in terms of health-related quality of life in patients with otosclerosis-was translated into Danish in a three-step process according to the guidelines provided by the International Collegium of Rehabilitative Audiology. In total, 35 patients with otosclerosis were included as cases and 35 individuals without ear-problems as controls. The SPOT-25 questionnaire was filled out once by the patients and twice by the controls. Pure tone average (0.5, 1, 2, and 3 kHz) (PTA4) was obtained for cases. RESULTS: The SPOT-25 clearly discriminated the individuals with otosclerosis from con-trols within all subscores (p<0.001). The internal consistency within the subscores was good to excellent with Cronbach alpha values of 0.85-0.95. The reproducibility (estimated by the control group) was moderate to high, with an intraclass correlation of 0.58-0.94 within the subscores. Although the SPOT-25 subscores within "hearing" and "social restrictions" showed a moderate correlation with PTA4 (Pearson correlation coefficient 0.51 and 0.42, respectively), this was not the case for the subscores regarding "tinnitus," "mental condition," and the "general." CONCLUSION: The SPOT-25 questionnaire can be used as a valuable complement to audiometric data in patients with otosclerosis, especially for estimating factors such as tinnitus and "mental condition," which do not correlate with the audiometric data.

Using betahistine in the treatment of patients with Menière's disease: a meta-analysis with the current randomized-controlled evidence.

Background: Betahistine is used worldwide to treat patients with Menière's disease. However, despite it being used for decades, diverging opinions on the effect of betahistine on Menière's symptomatology still exist.Aims: The objective of this systematic review was to provide an overview and rate the certainty of the current evidence base regarding the use of betahistine to treat patients with Menière's disease.Materials and methods: A systematic literature search was conducted in October 2019. The search strategy was subdivided into searches for existing guidelines, systematic reviews and individual randomized controlled trials (RCT) investigating the usage of betahistine as compared to placebo, in patients with Ménière's disease. The primary outcome was the frequency of vertigo attack(s) and occurrence of serious adverse events.Results: We identified three relevant guidelines and three systematic reviews: however, neither included any relevant trials matching our inclusion criteria. An individual search for RCTs identified one trial. The results from this particular trial showed no difference in effects on symptoms following treatment with betahistine.Conclusions and Significance: There is a need for further well-conducted placebo RCTs. Currently, there is still a lack of substantial evidence supporting betahistine as a significant and adequate treatment for patients diagnosed with Menière's disease. Trial registration number: The protocol is registered in PROSPERO. Registration number: CRD42018110127 Accepted 11.10.2018.

Recurrence of Cholesteatoma: A Retrospective Study Including 1006 Patients for More than 33 Years

Abstract Introduction Cholesteatomas are benign tumors consisting of skin, and growing inside a retraction pocket in the tympanic membrane. Cholesteatomas can occupy the entirety of the middle ear, and are known for their osteolytic capabilities. Surgery is the only curative treatment for cholesteatomas. Objective To describe the risk of recurrence after first-time surgically-treated middle- ear cholesteatoma (STMEC1) on the island of Funen from 1983 to 2015. Methods Cases of STMEC1 were identified in the Danish National Hospital Register. The medical records were reviewed. Time-to-event analyses were applied. The ears were followed from STMEC1 to a secondary cholesteatoma, emigration, death, or end of follow-up. Results Records from 1,006 patients with STMEC1 were reviewed. A total of 54 patients were submitted to surgery on both ears. The total sample consisted of 1,060 ears with STMEC1; 300 were children's (< 16 years) ears, and 760 were adult's ears. The total observation time was of 12,049 years. The overall estimated proportion with recurrence 5 years after surgery was of 37% in children and of 15% in adults. The older the child was at the first surgery, the risk decreased by 7% per year. In children, canal wall up (CWU) mastoidectomy without obliteration was associated with a hazard ratio for recurrence of 1.9 (95% confidence interval [95%CI]: 1.2-3.0) compared with CWU with obliteration. Conclusion Compared with adults, children were had 2.6 times more risk of recurrence. Procedures performed without mastoidectomy had the lowest risk of recurrence. In children, obliteration was associated with a significantly lower risk of recurrence. However, patients were not randomized regarding the surgical approach; thus, the association between approach and risk of recurrence was likely influenced by confounding factors.

[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.

Recurrence of Cholesteatoma - A Retrospective Study Including 1,006 Patients for More than 33 Years.

Introduction Cholesteatomas are benign tumors consisting of skin, and growing inside a retraction pocket in the tympanic membrane. Cholesteatomas can occupy the entirety of the middle ear, and are known for their osteolytic capabilities. Surgery is the only curative treatment for cholesteatomas. Objective To describe the risk of recurrence after first-time surgically-treated middle-ear cholesteatoma (STMEC1) on the island of Funen from 1983 to 2015. Methods Cases of STMEC1 were identified in the Danish National Hospital Register. The medical records were reviewed. Time-to-event analyses were applied. The ears were followed from STMEC1 to a secondary cholesteatoma, emigration, death, or end of follow-up. Results Records from 1,006 patients with STMEC1 were reviewed. A total of 54 patients were submitted to surgery on both ears. The total sample consisted of 1,060 ears with STMEC1; 300 were children's (< 16 years) ears, and 760 were adult's ears. The total observation time was of 12,049 years. The overall estimated proportion with recurrence 5 years after surgery was of 37% in children and of 15% in adults. The older the child was at the first surgery, the risk decreased by 7% per year. In children, canal wall up (CWU) mastoidectomy without obliteration was associated with a hazard ratio for recurrence of 1.9 (95% confidence interval [95%CI]: 1.2-3.0) compared with CWU with obliteration. Conclusion Compared with adults, children were had 2.6 times more risk of recurrence. Procedures performed without mastoidectomy had the lowest risk of recurrence. In children, obliteration was associated with a significantly lower risk of recurrence. However, patients were not randomized regarding the surgical approach; thus, the association between approach and risk of recurrence was likely influenced by confounding factors.

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.