Sleep Apnea

Researchers are evaluating a new hospital incubator pad that provides stochastic vibrotactile stimulation (SVS) as a complementary treatment for apnea of prematurity (AOP), a common condition in preterm infants where breathing stops for 20 seconds or more. This study aims to establish the safety, effectiveness, and clinical risks and benefits of this device, which could improve management of AOP beyond the current standard therapy of caffeine citrate. The study focuses on newborns born before 33 weeks gestational age and younger than 38 weeks postmenstrual age at enrollment. The study compares two groups: one receiving standard therapy with caffeine citrate plus continuous SVS stimulation via the Prapela SVS incubator pad, and a control group receiving standard therapy with an inert pad that looks identical but does not vibrate. Treatment with the SVS pad continues until the infant is apnea-free for three days and less than two weeks from anticipated discharge, or until the clinician decides to stop. If apnea returns after stopping, treatment may be restarted. Follow-up surveys will be conducted by telephone at 1 and 2 years of age to assess neurological development. Participants will be monitored closely with clinical evaluations and questionnaires completed by clinicians to assess risks and benefits. The primary outcome is the change in apnea rate during 7 to 28 days of intervention, with secondary outcomes assessed at earlier time points. The study is randomized and single-masked, with safety and efficacy data gathered to support possible FDA clearance and future use of the SVS incubator pad as an adjunctive therapy to improve outcomes in preterm infants with AOP.

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are studying obstructive sleep apnea syndrome (OSAS), a sleep disorder marked by loud snoring and repeated airway blockages during sleep that cause daytime tiredness. This observational study aims to create a prospective database to track changes in the upper airway volume and anatomy after maxillomandibular advancement (MMA) surgery, along with measuring the apnea-hypopnea index (AHI) and patients' quality of life. The study collects detailed data on patient demographics, virtual 3D cone-beam CT (CBCT) surgical planning, orthognathic surgery details, sleep study results, and quality of life assessments as part of routine care.

Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating how Continuous Positive Airway Pressure (CPAP) treatment affects blood pressure in adults aged 18 to 70 who have obstructive sleep apnea (OSA) and high or uncontrolled blood pressure. The study aims to find out which patients benefit the most in blood pressure reduction from CPAP and whether adding a sleep aid medication can improve CPAP effectiveness for those who experience insomnia or frequent awakenings at night. This observational study is sponsored by Beijing Anzhen Hospital and focuses on blood pressure control and sleep quality in OSA patients. Participants will use an auto-titrating CPAP device for at least 4 hours each night and at least 21 nights per month over about 3 months, with fitted masks and support to encourage use. Those with difficulty sleeping may also choose to take a short course of sleep aid medication (trazodone or zopiclone) for 4 weeks. The study forms natural sub-groups based on these interventions: CPAP only, CPAP plus trazodone, CPAP plus zopiclone, or drug only for those who decline CPAP. During the study, participants will undergo full-night sleep monitoring and 24-hour blood pressure monitoring to tailor CPAP pressure. Researchers will use questionnaires, actigraphy wristwatches, and additional sleep studies to observe changes in sleep and blood pressure. Blood and urine samples will be collected for safety checks. Participants are free to withdraw anytime without penalty, and study-related care including devices, medications, and tests are provided at no cost. The primary outcome measured is blood pressure after 3 months of CPAP treatment.

Researchers are investigating how obstructive sleep apnea (OSA) affects fat tissue and its role in increasing the risk of cardiovascular disease. This study focuses on examining the cellular and molecular changes in fat tissue of adults with OSA compared to healthy individuals. It aims to better understand how damaged fat tissue may contribute to insulin resistance, inflammation, and higher blood pressure in people with OSA. The study involves comparing fat tissue samples from two groups: those with obstructive sleep apnea (defined by an Apnea Hypopnea Index of 5 or higher) and those without it (AHI less than 5). Researchers will analyze markers of cellular damage in the fat tissue, such as p16 and gamma H2AX, to identify differences. The study is observational and does not involve treatment, focusing on tissue analysis and cardiovascular health markers. Participants will undergo assessments including fat tissue sampling to measure cellular damage markers, body composition analysis, blood pressure monitoring over 24 hours, evaluation of vascular function, and insulin sensitivity tests. The primary outcome is the prevalence of specific damaged cells in fat tissue. The total study duration and visits are arranged to gather this data, with no investigational treatments administered. The study is sponsored by the Mayo Clinic and includes adults aged 18 to 60 years.

This research aims to evaluate a culturally relevant micronutrient-dense plant-rich (mNDPR) dietary intervention designed to reduce obesity and related disease risks among Native American employees of Twin Arrows Casino. Native Americans face higher rates of obesity and Type II diabetes compared to non-Hispanic Whites. The study involves a randomized controlled trial to assess improvements in physical health measures, wellness, and healthcare costs over one year. Participants will be randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition program or a wait-list control group. The intervention includes a 2-hour initial group session followed by weekly 1-hour coaching sessions led by trained Native American Masters of Public Health students using Motivational Interviewing. Sessions provide nutrition education, cooking demonstrations, workplace dining tours, and social support. The wait-list control group will maintain usual eating habits during the first 12 weeks before receiving the same intervention. Participants will undergo health and wellness assessments at baseline and after 13 weeks, with additional diet recall at week 26 for the experimental group and follow-up measures for the control group. Healthcare utilization will be reviewed at 52 weeks. Researchers will measure changes in Hemoglobin A1c, fasting glucose, insulin, blood lipids, inflammatory markers, blood pressure, and wellness indicators like anxiety and sleep quality. Adherence to the diet will be monitored weekly, alongside attendance and self-monitoring of diet compliance.

Researchers are evaluating the effectiveness of the Care2Sleep behavioral sleep intervention program for people with Alzheimer's disease or related dementias and their caregivers. This randomized controlled trial lasts 5 years and focuses on improving sleep quality, health status, quality of life for both patients and caregivers, and inflammation levels in caregivers. The study uses Stage II of the NIH behavioral intervention development model to assess these effects. Participants will be assigned randomly to one of three groups: in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. Both Care2Sleep programs involve manual-based sleep hygiene recommendations, behavioral sleep intervention, and sleep compression therapy, delivered in five sessions. The education control group receives general information on sleep, aging, and dementia without personalized recommendations. The intervention and control programs start after baseline assessments and randomization. Participants will complete assessments immediately after the last session and again at 6 months to measure sleep efficiency and Pittsburgh Sleep Quality Index scores. Other evaluations include memory and behavior problems, quality of life, caregiver burden, depression, global health, and inflammatory markers. Safety and adherence are monitored, and the total participation duration spans from baseline through a 6-month follow-up.