Clinical Research Directory

A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)

This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \[OSA\]) and overweight or obesity who are not using a breathing machine (positive airway pressure \[PAP\] machine). People may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been unable or unwilling using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training. During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.

Different Flow Rates on Gas Exchange in Children During Apnea

Background: Children desaturate rapidly during apnea following anesthetic induction. The optimal apneic oxygenation flow rate and its effect on CO2 accumulation remain unclear. Objective: To compare nasal oxygen at 2, 4, and 8 L/min on the rise in arterial partial pressure of CO2 (PaCO2) between minutes 2 and 3 of apnea (primary outcome), oxygenation, and safety in anesthetized children.

A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)

This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \[OSA\]) and overweight or obesity who use a breathing machine (positive airway pressure \[PAP\] machine). People may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training. During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

Impact of Swaddle Blanket on Gastroesophageal Reflux

Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.

Intraocular Pressure During Static Apnea

This prospective observational study evaluated changes in intraocular pressure (IOP) during dry static apnea (STA) in breath-hold divers. Forty participants performed voluntary breath-holds while intraocular pressure, peripheral oxygen saturation (SpO2), heart rate, and blood pressure were measured at baseline, during apnea, and after apnea. The aim was to assess the magnitude and dynamics of IOP changes and their relationship to physiological parameters.

Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion

Breathing is a crucial function for everyone. Breathing impairment in children could lead to behavioral and cognitive problems at least. But what if orthodontic treatment could help those patients to breathe better, with less effort? This research proposal aims to find out if the increase in the upper airway volume seen in some research results can be related to a decrease in respiratory effort and an improvement in the breathing capacity of those patients. In other words, if a tube shape is changed or if a tube is enlarged, would the airflow passing inside the tube change in velocity? Or would there be more air? Therefore, investigating the pressure/airflow, volume/lumen relation and its possible changes after mandibular repositioning and maxillary expansion in children will lead to a better understanding of how orthodontics could potentially affect the upper airway. Previous studies have reported a link between mandibular advancement appliances and maxillary appliances to an increase in the upper airway volume. However, more studies are needed to evaluate the relationship between the changes in the upper airway volume and actual airflow and respiratory capability. The airway volume measurement is important to, preliminary, state if there is an increase in the upper airway after orthodontic treatment. However a change in shape, even with the same volume, can affect the pressure and airflow. In this sense, the pressure drop analysis will allow an answer to those questions

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.

Non-inferiority Analysis of Two Titration Methods for Hypoglossal Nerve Stimulation Therapy

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated. The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.

The Role of Oxygen Reserve Index (ORi) in Apneic Ventilation

Background: The Oxygen Reserve Index (ORI) is a non-invasive parameter utilizing multi-wavelength pulse co-oximetry. ORI can provide early warnings of deteriorating oxygenation before changes are reflected in SpO₂ levels. This study aimed to investigate the feasibility of non-ventilated intubation in patients undergoing cholecystectomy as a means to achieve safe intubation without nasogastric tube placement, with reduced trauma and cost, and improved time efficiency.

Effects of Walking Apnea At High Lung Volume on Hypoalgesia

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.