Laryngitis

Gastroesophageal reflux disease (GERD) occurs when stomach acid flows back into the esophagus and throat, causing symptoms like heartburn, acid regurgitation, throat irritation, hoarseness, difficulty swallowing, and a dry cough. This condition may be caused by weak lower esophageal sphincter muscles, hiatal hernia, or movement disorders in the esophagus or stomach. Researchers are exploring whether voice samples can detect characteristic changes related to reflux, potentially offering a simple, non-invasive way to identify this condition early. This observational study involves patients undergoing standard diagnostic tests for reflux, including gastroscopy, esophageal manometry, and 24-hour impedance pH measurement. Participants will be grouped into those with confirmed reflux and those without. Voice recordings and questionnaires will be collected at diagnosis and, for reflux patients, again five months after starting treatment. The recordings will be digitally analyzed for typical vocal changes associated with reflux by a Swiss technology center. Participants will provide voice samples via microphone and complete questionnaires without needing extra hospital visits. The study lasts up to five months and stores data securely in encrypted form following strict privacy rules. Researchers aim to identify vocal markers linked to reflux and understand how they relate to symptoms and treatment effects, with results expected in 2025.

Researchers are evaluating the safety, tolerability, and effectiveness of the gene therapy SENS-501 in children aged 6 to 31 months who have severe to profound hearing loss caused by mutations in the Otoferlin gene. This open-label Phase I/II study focuses on children with pre-lingual hearing loss due to these genetic mutations, aiming to better understand how this treatment works in this young population. The study involves administering SENS-501 directly into one ear using a special injection system. It includes a dose-escalation phase where children receive either a low or high dose, followed by a dose expansion phase where the dose recommended from earlier phases is given. The treatment is given as a single unilateral intracochlear injection, and the administration system's safety, performance, and usability are also evaluated. Participants will be followed for up to 5 years to monitor safety and tolerability and to assess hearing improvement using auditory brainstem response (ABR) and pure tone audiometry (PTA). Additional evaluations include clinical checks of the administration system shortly after treatment. Throughout the study, children will undergo hearing tests and medical assessments to measure outcomes and track any side effects or complications from the treatment and procedure.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy (SBRT) to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

Researchers are conducting a Phase 1, open-label, randomized crossover study to evaluate how the study drug ibuzatrelvir is absorbed into the bloodstream of healthy adults. The trial compares the amount of ibuzatrelvir in blood after taking different tablet formulations, including the original and new tablets, both with and without food. The study also assesses the safety and tolerability of the medication. Participants will take a single dose of ibuzatrelvir in four different ways across four dosing periods: the original tablet fasted, the new tablet fasted, the new tablet dispersed in water fasted, and the new tablet fed. Each dosing period lasts 2 to 3 days, and participants will stay in the clinical research unit for 9 nights and 10 days to complete all dosing and procedures. The study uses a crossover design where each participant receives all treatment types in varied sequences. During the study, participants will have blood and urine samples collected for safety and to measure drug levels, with up to 40 blood draws for pharmacokinetics. They will also undergo up to 8 ECGs to monitor heart activity. Participants must fast overnight before most doses. After the inpatient stay, a follow-up phone call will occur 28 to 35 days after the last dose. Total participation lasts about 10 to 11 weeks.

Researchers are studying the accuracy of a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) to measure throat sensitivity in patients suspected of having obstructive sleep apnea (OSA). This prospective, double-blinded, randomized crossover trial aims to validate this device's measurements by comparing them to standard sleep study results. The study focuses on understanding sensory differences in patients with mild, moderate, and severe OSA and improving knowledge about OSA’s underlying mechanisms. The study involves patients referred for a baseline sleep test who will undergo a sensory test using the LPEER, which delivers air pulses of varying intensity to specific throat areas: the velopharynx, hypopharynx, and aryepiglottic folds. Experienced and less experienced pulmonologists or otolaryngologists will perform these tests to assess measurement reliability. The study design includes randomized crossover assignment of raters to evaluate intra- and inter-rater agreement and diagnostic accuracy through detailed statistical analyses. Participants will attend the sleep laboratory where they will receive the sensory test alongside their routine sleep study. Researchers will measure sensory thresholds at three throat sites and collect data related to sleep apnea severity, oxygen levels, and any adverse events. The study will last up to 15 days for each participant, during which safety and test accuracy will be closely monitored. Results will help determine the usefulness of LPEER for future clinical evaluation and monitoring of OSA patients.

Researchers are evaluating the effects of acupressure on cough and related symptoms such as shortness of breath and fatigue in lung cancer survivors. This randomized controlled trial aims to see if acupressure can reduce these symptoms, improve symptom burden, and enhance health-related quality of life and functional ability in patients with lung cancer. The study addresses the significant impact that cough and its related symptoms have on lung cancer survivors' quality of life and overall survival. Participants are randomly assigned to one of two groups: one group receives an 8-week acupressure intervention, while the other receives an educational booklet about lung cancer, cough causes, and management. The acupressure group attends two hospital training sessions in the first week to learn the technique, then performs acupressure daily on 15 specific points twice a day and during coughing episodes as needed. The education group receives the booklet after baseline assessment and will be offered acupressure later after the study ends. Participants keep diaries of their acupressure practice and symptoms and are assessed four times: before starting (baseline), after one week, after eight weeks, and eight weeks after the intervention ends. Researchers measure cough, quality of life related to cough, symptom clusters, fatigue, shortness of breath, symptom burden, functional capacity, and overall health-related quality of life. Follow-up continues for 16 weeks to monitor lasting effects and safety throughout the study period.

Researchers are evaluating the ability of the AeviceMD, a wearable medical device, to detect wheezing in both children and adults. Wheezing, cough, and breathlessness are common respiratory symptoms usually identified manually by healthcare professionals through listening to lung sounds. The study aims to find out if AeviceMD can detect wheezes as accurately as a physician and to explore its potential for remote lung sound monitoring. During the study, participants will have the AeviceMD device placed on them to record lung sounds and detect wheezes. The device's findings will be compared with assessments made by physicians through traditional auscultation. The study includes two groups: patients diagnosed with acute asthma exacerbations and patients with other non-cardiac and non-pulmonary complaints. Participants will undergo lung sound recordings both onsite with a physician and remotely, with the results compared between the AeviceMD device and medical professionals. The primary outcome is the detection of wheeze within 60 seconds, while the secondary outcome involves identifying respiratory sounds within 150 seconds. The study is observational and will continue until December 2026, involving children aged 3 years and older.

Researchers are evaluating an artificial intelligence-assisted system designed to improve the detection of anatomical sites and lesions during nasopharyngolaryngoscopy, a procedure used to examine the nasopharynx and larynx. The study aims to address challenges of traditional procedures such as incomplete visualization and unclear imaging by training and validating a deep learning model using collected images and patient data from multiple centers. The study involves collecting electronic nasopharyngolaryngoscopy images and baseline patient information, including gender and age, to train and validate the AI model. Initially, the model is trained using a retrospective dataset and internally validated. Subsequently, the clinical performance of the model is assessed prospectively by enrolling patients, collecting new nasopharyngolaryngoscopy videos, and testing the model against this independent dataset. Participants will undergo standard nasopharyngolaryngoscopy exams, with their images and videos collected for analysis. Researchers will compare the model’s lesion detection and anatomic site recognition performance to that of physicians. Outcome measures are evaluated within three months after completing data collection. The study runs from December 2025 to March 2027 and includes assessments of diagnostic accuracy and comparative performance between the AI system and medical professionals.

Researchers are investigating whether adding a diagnostic test that can distinguish whether an acute respiratory illness is caused by bacteria or viruses early in the evaluation can improve patient management and reduce healthcare resource use. The study focuses on adults presenting to the Emergency Department (ED) with undiagnosed respiratory infections who meet SIRS criteria and require immediate blood tests and treatment. The goal is to see if this test affects decisions about further diagnostic work, antimicrobial use, hospital stay length, and related costs. Participants are randomly assigned to one of two groups. The experimental group receives the usual care plus results from the MeMed BVae biomarker test, which analyzes a blood sample to provide a score that may help guide treatment. The control group receives standard care without the test results. Both groups are managed by clinicians following standard practice protocols. The study aims to compare outcomes such as additional testing, use of antibiotics, hospital admissions, and length of stay between these groups. During the study, participants will be monitored from admission to the ED through about 28 days of follow-up. Researchers will track costs related to diagnostic tests, consultations, antimicrobial treatments, hospital stays, and emergency department visits. They will also assess hospital length of stay up to six months post-admission, the number of patients returning to the ED within 72 hours, and appropriate antibiotic use based on infection type. Safety and patient management quality will be evaluated by reviewing these clinical and resource measures.

Researchers are investigating how people with cochlear implants (CIs) perceive and enjoy music, comparing them with individuals who have normal hearing. The study includes both children aged 6 to 17 who were implanted before age 3 and adults who lost hearing after learning to speak. It also examines voice quality in CI users and looks for links between musical perception and voice characteristics. The study uses specific questionnaires and musical tools to assess these abilities. Participants undergo a one-time evaluation including completing music-related questionnaires suitable for adults and children, using the Meludia music tool to test musical perception, and voice analysis with specialized software. The study includes both CI users and a control group of normal hearing peers matched by age and other factors. The assessments can be done in person or remotely, using devices connected directly to the cochlear implants. During the study visit, participants complete questionnaires with assistance if needed and perform musical perception exercises lasting about an hour. Their voice is recorded for acoustic analysis. Audiological data and clinical histories are reviewed for those with implants. All tests are done once without follow-up, as no changes are expected over time. The study aims to validate questionnaires and analyze how hearing and demographic factors relate to music perception and voice quality in CI users compared to normal hearing individuals.