Central Sleep Apnea

The trial investigates the WatchPAT (WP) device's ability to detect sleep disorders compared to the gold standard polysomnography (PSG) in patients suspected of sleep disorders. Participants include individuals referred for sleep studies or those with comorbidities related to central sleep apnea. The study is prospective and blinded, aiming to gather data on the WP device's performance during clinical sleep evaluations. Participants will spend one night in a clinical sleep laboratory where they will simultaneously wear the WP device with a finger probe and chest sensor while undergoing a full-night PSG recording with standard channels. The PSG data will be recorded and manually scored without access to WP data to maintain blinding, while the WP device data will be analyzed automatically. This design allows comparison between the WP device and PSG results. During the study night, demographic and medical information will be collected from participants or their medical charts. Researchers will assess the Apnea-Hypopnea Index (AHI) and sleep stages from one night of sleep as primary outcomes, with the Respiratory Disturbance Index (RDI) as a secondary outcome. The study involves a single overnight visit with no long-term follow-up, focusing on accurately measuring sleep disorder indicators through both methods.

Researchers are evaluating the safety and effectiveness of IBI362 in adults with moderate-to-severe obstructive sleep apnea (OSA) who have a body mass index (BMI) of 28 kg/m2 or higher. This Phase III study involves multiple centers and compares IBI362 to a placebo to better understand its impact on OSA symptoms and related health measures. Participants will be randomly assigned to receive either IBI362 or a placebo through weekly subcutaneous injections. The IBI362 dosage will increase gradually over the initial 12 weeks, starting from 2 mg once a week for 4 weeks, then 4 mg once a week for 4 weeks, followed by 6 mg once a week for 4 weeks, and finally 9 mg once a week for 36 weeks. The study includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week follow-up period after stopping the study drug. Throughout the trial, participants will undergo regular assessments including sleep studies to measure apnea-hypopnea index (AHI), body weight, blood pressure, and sleepiness scales. Researchers will monitor changes from baseline in these measures at Week 48. The safety and adherence to treatments will be closely tracked, and a final follow-up will occur 12 weeks after treatment ends. Total participation spans approximately 64 weeks.

Researchers are evaluating the safety, tolerability, and how the body processes a drug called ORX142 in healthy adults aged 18 to 80 years. This Phase 1 clinical trial includes several parts to study single and multiple doses, the effects of food on the drug, and tests in both younger and older adults, as well as in people who have been acutely sleep-deprived. The study aims to understand the drug's effects on excessive daytime sleepiness. Participants will receive ORX142 or placebo tablets in different parts of the study. Parts A, B, and C focus on single and multiple ascending doses in healthy adults, with Part B examining the food effect on the drug. Part D studies single doses in healthy older adults, while Part E tests the drug in acutely sleep-deprived healthy adults. The study uses a randomized, double-blind, placebo-controlled design. During the trial, participants will be closely monitored for side effects and treatment-emergent adverse events from enrollment until 13 days after discharge. Blood samples will be taken before and after dosing to measure drug levels and how the body processes it over time. Sleepiness will be assessed using tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale in Part E. Overall participation duration varies depending on the part of the study involved.

This research aims to evaluate whether acetazolamide can improve central sleep apnea (CSA) caused by medications used to treat opioid use disorder (MOUD), such as methadone and buprenorphine. The study explores if improving CSA can lead to changes in physiological factors like drug craving, anxiety, and cognitive function, which may impact health outcomes in patients with opioid-induced CSA. This is a phase 2 mechanistic trial focused on understanding these effects. Participants who have central sleep apnea while on MOUD will be randomly assigned to receive either acetazolamide 250 mg or a matching placebo once daily in the evening for 7 days. After the treatment period, participants will undergo an overnight sleep study to assess breathing during sleep and sleep quality. The study compares the effects of acetazolamide versus placebo on sleep and related physiological outcomes. During the study, participants will have overnight polysomnography and assessments of autonomic tone, sleep quality, nocturnal arousal, emotional distress, cognitive function, and drug craving. The main outcome measured is the Central Apnea Index after 7 days of treatment. Additional measures include the low frequency/high frequency ratio and the Apnea Hypopnea Index. The total participation involves the initial screening and a 7-day treatment followed by outcome assessments.

Researchers are studying ways to reduce unintentional oral leaks that occur during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). This trial focuses on comparing different CPAP methods to manage leaks, as no standard approach currently exists. Higher CPAP levels are linked to more leaks, so the study aims to test strategies to control this issue effectively.

Researchers are investigating how to manage unintentional oral leaks that occur during continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). This study focuses on evaluating different mask types and strategies to reduce excessive leaks, which are common side effects that have not been standardized or well studied. The trial is part of a controlled, randomized crossover design to compare oral leaks with oronasal masks versus nasal masks combined with chinstraps. Participants who continue to have excessive leaks after an initial phase (Study A) will enter Study B, where they will use CPAP with either an oronasal mask or a nasal mask plus chinstrap for 7 days each. The order of these interventions will be randomized and separated by a 7-day washout period using nasal CPAP alone. This sequence will allow comparison of leak control between the two mask approaches. During the study, participants will be monitored for unintentional leak levels, sleep apnea severity, and side effects using questionnaires such as the CPAP Side-effects questionnaire, the Functional Outcomes of Sleep Questionnaire, and the Pittsburgh questionnaire. The main outcome is the 95th percentile of unintentional leak measured over 27 days. The total study duration includes both intervention periods and washout, with assessments conducted throughout to evaluate treatment effects and participant experience.

Researchers are evaluating whether bexagliflozin can lower the severity of sleep apnea in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA). The study aims to see if this drug reduces anatomical and physiological traits linked to OSA and improves clinical measures of sleep apnea and sleep deficiency. Participants will receive either the drug or a placebo, with normal care maintained for six months. Participants are randomly assigned to take either bexagliflozin 20 mg once daily or a matching placebo daily for six months. Both groups will continue their usual clinical care during this period. Measurements are taken at the start and end of the study, including MRI scans to assess fat and airway structures, sleep studies to measure apnea and oxygen levels, blood tests, and other assessments of sleep quality and body composition. Throughout the study, participants will undergo various evaluations such as full ambulatory polysomnography, MRI imaging, blood biomarkers, neck circumference measurements, and questionnaires about sleep quality and daytime sleepiness. These assessments occur at baseline, three months, and six months to monitor changes. The primary outcome measure is the change in the apnea hypopnea index (AHI) after six months. Safety and adherence will be monitored during the entire study period.

Researchers are studying the occurrence of major heart and brain-related events in patients after their first stroke, first transient ischemic attack (TIA), or recurrent TIA. This research compares patients with sleep-disordered breathing (SDB) to those without SDB one year after diagnosing SDB three months post-stroke. The primary focus is on a combined measure of serious cardiac or brain events including death, non-fatal stroke, and acute coronary disease. The study includes 1620 patients aged 18 to 85 who are in the acute phase of a stroke or TIA and have low disability before the event. Patients will be grouped based on polysomnography results performed three months after their stroke or TIA to diagnose SDB, defined by an apnea-hypopnea index higher than 15 events per hour. Those with SDB will receive treatment according to standard care, such as Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, positional therapy, adaptive servo-ventilation, or non-invasive ventilation. The study follows patients over five years, with assessments at enrollment, three months, and annually after SDB diagnosis. Participants undergo detailed clinical, imaging, cognitive, sensorimotor, and biological evaluations at various points, including stroke imaging, blood sampling, and questionnaires on quality of life, depression, and sleep. Regular follow-up assesses new cardiac or cerebrovascular events, stroke-related outcomes, treatment adherence, and cognitive and functional abilities. An ancillary study focuses on patients eligible for carotid surgery, evaluating plaque changes and molecular markers. The primary outcome measure is collected one year after SDB diagnosis, with long-term monitoring continuing up to five years.

Researchers are conducting a prospective, longitudinal natural history study to understand the clinical progression of children and adults with Synaptotagmin1-Associated Neurodevelopmental Disorder, also known as Baker Gordon Syndrome (BAGOS). The study aims to develop effective outcome measures and diagnostic tools to prepare for future clinical trials, focusing on demographic, genetic, environmental factors, treatments, and medications linked to the disorder's development and outcomes. Participants will undergo various assessments including standard scales and questionnaires to evaluate global development, language, memory, and motor functions. They will keep sleep and seizure diaries, provide a small blood sample for whole genome sequencing and proteomic analysis, and have brain imaging via MRI and electroencephalography (EEG) to identify disease biomarkers. A small skin sample will be collected to develop patient-specific stem cells for further research on the impact of Synaptotagmin1 mutations. During the 24-month study, participants and their caregivers will be assessed using neurological and disability evaluation scales, behavior assessments, and other developmental tests. Researchers will collect medical data, monitor motor milestones, and evaluate sleep and attention. Caregivers and legal representatives will also participate by completing questionnaires and consenting to study procedures. The goal is to enhance understanding of BAGOS and prepare the healthcare system for future treatments.

Central sleep apnea (CSA) involves periods during sleep when breathing temporarily stops or decreases due to a lack of effort to breathe. This condition can cause excessive daytime sleepiness and poor sleep quality and is linked to higher mortality in patients with heart failure. Researchers are studying the factors that influence treatment choices and how well patients follow these treatments for CSA in Belgium, as well as the effects of these treatments. Participants in this study will receive routine care as part of a registry, without additional interventions from the study. Eligible participants have a confirmed diagnosis of CSA based on specific breathing event measurements from sleep studies. This observational study will follow patients over five years to monitor their treatment decisions, compliance with treatments, and health outcomes. Throughout the study, participants' treatment choices and compliance will be tracked along with assessments of their health-related quality of life and sleep quality using surveys like the Short Form 36 Health Survey and Pittsburgh Sleep Quality Index. Researchers will also monitor mortality over the five-year period. The study involves regular evaluations but no experimental treatments, focusing on real-world data collection to better understand CSA management.