Nasal Obstruction

Researchers are investigating the use of three-dimensional (3D) printing technology to improve nasal irrigation outcomes for adults with chronic rhinosinusitis, with or without nasal polyps. Chronic rhinosinusitis is a common condition causing nasal obstruction, facial pain, nasal discharge, and loss of smell, significantly affecting quality of life. This study aims to personalize nasal irrigation techniques based on individual nasal anatomy to enhance treatment effectiveness and patient satisfaction, especially for those who are not candidates for surgery or prefer less invasive options. Participants use a 3D-printed nasal replica derived from their CT scans to help determine the best head position for nasal irrigation. The study compares three groups: a control group using the standard FDA-recommended head position, a backfill group using a specific 90-degree ear-to-shoulder tilt, and a model group using a personalized optimal position based on their 3D nasal replica. All participants irrigate their sinuses once daily with 2 mg mometasone in 240 mL NeilMed sinus rinse bottles for 8 weeks. During the study, participants complete symptom evaluations including the Nasal Obstruction Symptom Evaluation (NOSE) score, 22-item Sino-Nasal Outcome Test (SNOT-22), and Visual Analogue Scale (VAS) for nasal congestion at baseline and after 8 weeks of treatment. CT scans assess sinus inflammation using the Lund-Mackay (LM) score at the same time points. The study monitors patient adherence and collects data to evaluate whether personalized irrigation improves quality of life and nasal symptom relief over the 8-week treatment period.

Researchers are evaluating the effects of two types of maxillary expanders used to widen the upper jaw in children aged 8 to 13 years with maxillary transverse deficiency. This trial compares a traditional expander made by hand in a laboratory to a newer expander designed on a computer and produced with 3D printing technology. The goal is to determine if the 3D-printed expander is as effective as the conventional one while potentially offering greater comfort to the patient. Participants will be randomly assigned to two groups: one group receives the conventional laboratory-made Hyrax expander, and the other group receives the 3D-printed Hyrax expander. Both devices are used in the orthodontic clinic to treat upper jaw expansion. The treatment period includes follow-up visits over six months where dental photos, X-rays, and scans are taken to monitor progress. Patients and their parents or guardians will also complete online questionnaires about quality of life and pain experienced at various times during the study. During the study, participants will attend regular clinical visits for standard orthodontic follow-up, including photos, X-rays, and dental scans to assess the expander's effects. Researchers will measure changes in the midpalatal suture opening, interincisal diastema width, molar inclination, and maxillary arch widths after two weeks. Pain perception and oral health-related quality of life will also be evaluated using specific pain scales and questionnaires. This study lasts six months, with ongoing monitoring of treatment progress and patient comfort.

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

This research aims to develop and test a modified minimally invasive surgical technique for sinus floor augmentation in patients with a residual bone height of 3 to 6 millimeters. The goal is to create a reliable implant bed of at least 10 millimeters in height after a healing period of 3 to 5 months. The study also seeks to reduce patient stress compared to traditional methods. Participants will undergo the sinus floor elevation procedure, which is being evaluated to improve outcomes and comfort. This surgical technique is studied on a pilot group of 12 patients, with no placebo or comparative treatments involved. The procedure targets the maxillary sinus area to enhance bone structure for dental implant placement. During the study, participants will be monitored to measure the height of bone augmentation after 4 to 5 months of healing. The research team will assess the surgical results and patient recovery, including any side effects or complications. The total duration includes the surgery followed by the healing and evaluation period to determine the procedure's effectiveness and patient impact.

This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.

Researchers are evaluating the effects of tezepelumab treatment in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have been determined by their physician to be eligible for surgery. This phase IIIb, multicenter, open-label, single-arm study aims to describe changes in nasal congestion and overall sino-nasal symptoms after starting tezepelumab. The study includes participants with or without asthma and focuses on symptom improvements using patient-reported measures. Participants will receive a single dose of tezepelumab via subcutaneous injection every four weeks for up to 24 weeks. The study is organized into three periods: a screening period lasting up to four weeks before treatment begins, a 24-week treatment phase, and a 12-week safety follow-up period after treatment ends. Approximately 60 sites across 10 countries will enroll adults with surgery-eligible CRSwNP. During the study, participants will attend visits every four weeks for assessments, including symptom scores like nasal congestion and sino-nasal outcome tests. Researchers will monitor changes from baseline in these symptoms at multiple time points, along with other measures such as loss of smell, sleep quality, and nasal obstruction. Safety follow-up will continue for 12 weeks after treatment, allowing researchers to evaluate treatment outcomes and participant well-being throughout the study period, which lasts up to 40 weeks in total.

Researchers are evaluating the nasal polyps score and symptoms in Chinese adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) who begin treatment with tezepelumab. This Phase 3b, multicentre, open-label, single-arm study includes about 230 adults who have an eosinophilic type of this disease, defined by a JESREC score of 11 or higher, with about 30% having an even higher score of 15 or more. The study is sponsored by AstraZeneca and is designed to better understand how tezepelumab affects nasal polyps and related symptoms over time. Eligible participants will receive a fixed dose of 210 mg tezepelumab given as a subcutaneous injection every four weeks for 24 weeks, totaling six doses. All doses will be administered at the study sites. Since this is a single-arm study, all participants receive the same treatment without comparison to a placebo or other drug. The study specifically includes participants who have severe nasal polyps requiring surgery and ongoing symptoms despite standard treatments like intranasal corticosteroids. Participants will be closely monitored throughout the study from baseline to week 24. Researchers will assess changes in nasal polyp scores, nasal congestion, sino-nasal symptoms, sleep quality, sense of smell, and lung function for those with asthma. These assessments include patient questionnaires, nasal polyp scoring by central readers, peak nasal inspiratory flow measurements, and monitoring of exacerbations. The study also involves safety monitoring and will document participant responses over the treatment period to better understand tezepelumab's effects on CRSwNP symptoms and disease control.

This research aims to describe postoperative outcomes, quality of life, disease control, and characteristics of Chinese patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have undergone surgery. It also evaluates the economic burden and post-operative treatment patterns in patients with recurrent CRSwNP. The study is prospective and conducted across multiple centers in China, enrolling around 200 patients diagnosed with CRSwNP and scheduled for surgical treatment. Participants will undergo standard-of-care endoscopic sinus surgery (ESS) performed according to routine clinical practice and local guidelines. This surgical procedure serves as the baseline event for prospective observation. Researchers will monitor clinical outcomes, including Sino-Nasal Outcome Test (SNOT)-22 scores, Nasal Polyp Scores, and CT findings, over a 52-week period following surgery. Treatment decisions remain under the discretion of treating physicians. During the study, participants will receive regular clinical assessments and follow-ups to track changes in symptoms, quality of life, medication use, and recurrence rates. Evaluations include questionnaires like SNOT-22, spirometry, CT scans, and various symptom scores at multiple time points up to one year. The study also observes systemic medication use and post-operative complications to provide a comprehensive view of patient outcomes and disease control after surgery.

Researchers are investigating early warning signs and biomarkers for dementia with Lewy bodies (DLB), a common cause of dementia linked to the buildup of misfolded alpha-synuclein protein in the brain. The study focuses on people with idiopathic olfactory dysfunction—loss or reduction of smell without known cause—to better understand symptom progression and improve early diagnosis, potentially aiding future treatments. Participants include people with and without olfactory dysfunction. The study uses Real-Time Quaking-Induced Conversion (RT-QuIC), a laboratory technique that detects misfolded alpha-synuclein, to assess samples from participants. It involves an exploratory cross-sectional case-control design and a long-term follow-up using Danish health registries to track diagnoses of Parkinson's disease or dementia. During the study, participants undergo smell tests, motor function exams, cognitive assessments, and evaluations of other symptoms related to Parkinson's disease and DLB at regular intervals over 24 months and longer. Researchers monitor the presence of misfolded alpha-synuclein and track diagnoses over up to 8 years. This observational study helps identify early signs and disease progression markers while participants continue their usual care.

Nasal sinus polyposis is a chronic inflammatory condition affecting the nasal cavity and sinuses, leading to multiple bilateral polyps. This condition affects 2 to 4% of the general population and is challenging to manage because current treatments often fail or lead to symptom recurrence. Researchers are studying the anatomical, clinical, and biological profiles of patients with severe nasal polyps to better predict how patients will respond to surgery and biotherapy treatments. The study involves identifying anatomo-clinico-biological correlations by examining the anatomopathological profile, clinical features, and cytokine signatures of nasal polyps. These profiles aim to guide patient management, especially for those resistant to medical treatments and requiring first-time surgical treatment such as ethmoidectomy. The research assesses these factors to help predict treatment response, including to newer biologic therapies. Participants will undergo evaluations including anatomical profiling, symptom assessment using a visual analogue scale, quality of life measurement with the Sino-Nasal Outcome Test, biological profiling, and cytokine concentration analysis in serum. These assessments occur on a single day. The study monitors symptom severity, quality of life, and biological markers to understand treatment resistance. Participation involves a one-day visit for these detailed evaluations under medical supervision.