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Hypoventilation clinical trials

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NCT ID: NCT05448443 Recruiting - Clinical trials for Obesity Hypoventilation Syndrome (OHS)

Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome

ATOHS
Start date: June 21, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo-controlled, cross-over, phase II, single center efficacy study of AD981 in patients with obesity hypoventilation syndrome documented by polysomnography (PSG) and transcutaneous, overnight measurement of CO2 (PtcCO2).

NCT ID: NCT05398068 Recruiting - Obesity Clinical Trials

Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Obesity Hypoventilation Syndrome is defined as a combination of obesity (BMI ≥ 30 kg/m2) and daytime hypercapnia in arterial blood gas analysis (PaCO2 > 45 mmHg) without other pathologies that cause hypoventilation. Symptoms seen in individuals diagnosed with OHS are stated as a feeling of suffocation due to apnea, loud snoring, morning headache and excessive daytime sleepiness. Respiratory mechanics, respiratory muscle performance, pulmonary gas exchange, lung functions and exercise capacity parameters are adversely affected in patients. Early treatment is important so that these negative changes do not lead to worse outcomes. Weight control, bariatric surgery, pharmacological treatment and non-invasive mechanical ventilation (NIMV) are included in the treatment program of OHS patients. The effects of exercise on the treatment program of OHS patients are unknown. Considering all the studies in the literature, the primary purpose of this study is to evaluate aerobic and strength training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters. In addition, the researchers believe that this study will form the basis for further scientific studies on OHS and exercise and will make an important contribution to the literature.

NCT ID: NCT04884165 Recruiting - COPD Clinical Trials

Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation

READ-NIV
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treated using home mechanical ventilation, also called non-invasive ventilation (NIV). Breathing difficulties during sleep affect many patients with conditions such as chronic pulmonary obstructive disease (COPD), neuromuscular conditions and obesity hypoventilation syndrome. Left untreated they can cause breathlessness, headaches, sleepiness and lead to hospitalisations and other severe adverse health outcomes. The best available treatment for chronic types of sleep-disordered breathing is NIV. However, not every patient eligible tolerates this treatment because it requires patients to sleep with a nasal or full-face mask that is connected with a tube to a machine. Although NIV is recommended by the National Institute for Health and Clinical Excellence (NICE), many patients who should be on NIV use the treatment insufficiently within months. Using remote monitoring to identify problems with treatment adherence early on may help to identify clinical problems, troubleshoot user- or device-dependent problems, avoid delays in treatment and safe healthcare resources in the long-term. The investigators invite patients who use NIV to participate in this trial when they have difficulties with the treatment (NIV). This study will evaluate compliance and efficacy of a remote monitoring device (T4P device, SRETT, Paris/France) that will be connected to the standard NIV machine to remotely monitor usage. Patients will be randomly assigned to the remote monitoring using NIV for three months at home, or to usual care which is NIV without this monitoring. The primary outcome measure of this study is the improvement in adherence and compliance, as indicated by the average usage of NIV, as well as symptom scores to assess treatment effects.

NCT ID: NCT04839419 Recruiting - Metabolic Syndrome Clinical Trials

Obesity-hypoventilation in Metabolic Syndrom Patients

Start date: August 1, 2020
Phase:
Study type: Observational

The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

NCT ID: NCT04688125 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy

Start date: June 17, 2021
Phase:
Study type: Observational

Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety of causes. Use of positive airway pressure (PAP) requires use of an interface, commonly referred to as a "mask." There are a range of mask options available, differing in configuration and sizing, including masks that fit into the nostrils (nasal pillows, NP), cover the nose (nasal masks, NM), cover both the nose and the mouth (oronasal masks, ONM), and rarely those that fit into the mouth (oral masks, OM) or over the entire face. The variety of masks, sizes, and materials result from the wide variety of facial configurations and patient preferences along with requirements to provide a good seal for varying pressure requirements. Failure to find a good match for a given patient may result in significant side effects, such as eye irritation owing to leak into the eyes, skin pressure sores, noise generation, and inadequate therapy when air leaks are extreme. Pressure sores, mask dislodgement, claustrophobic complaints, air leaks, and sore eyes occur in 20-50% of patients with OSA receiving PAP, and these effects negatively correlate with PAP compliance. Furthermore, several trials point to differences in compliance related to which types of masks are utilized. In a randomized cross-over trial, compliance was 1 hour more per night in patients using NM compared to those using ONM.1 In another, NPs were associated with fewer adverse effects and better subjective sleep quality than NMs.2 Therefore, failure to find an acceptable mask results in lower or non-compliance, and therefore treatment failure. Currently, finding a right mask is performed either using crude templates, or via an iterative process, variably guided by experts in mask fitting. There are no standard certifications or algorithms to guide mask fitting. Given the above, it would be very desirable to find a reliable method to reduce the errors in mask fitting so that the costs, inconvenience, and suffering are all reduced.

NCT ID: NCT04498598 Recruiting - Hypoxia Clinical Trials

Structural Modification In Supraglottic Airway Device

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.

NCT ID: NCT04484727 Recruiting - Clinical trials for Ventilator Associated Pneumonia

"Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"

LUNAR
Start date: May 1, 2022
Phase:
Study type: Observational

Little is known about how lung mechanics are affected during the very early phase after starting mechanical ventilation. Since the conventional method of measuring esophageal pressure is complicated, hard to interpret and expensive, there are no studies on lung mechanics on intensive care patients directly after intubation, during the first hours of ventilator treatment and forward until the ventilator treatment is withdrawn. Published studies have collected data using the standard methods from day 1 to 3 of ventilator treatment for respiratory system mechanics, i.e. the combined mechanics of lung and chest wall. Consequently, information on lung mechanical properties during the first critical hours of ventilator treatment is missing and individualization of ventilator care done on the basis of respiratory system mechanics, which are not representative of lung mechanics on an individual patient basis. We have developed a PEEP-step method based on a change of PEEP up and down in one or two steps, where the change in end-expiratory lung volume ΔEELV) is determined and lung compliance calculated as ΔEELV divided by ΔPEEP (CL = ΔEELV/ΔPEEP). This simple non-invasive method for separating lung and chest wall mechanics provides an opportunity to enhance the knowledge of lung compliance and the transpulmonary pressure. After the two-PEEP-step procedure, the PEEP level where transpulmonary driving pressure is lowest can be calculated for any chosen tidal volume. The aim of the present study in the ICU is to survey lung mechanics from start of mechanical ventilation until extubation and to determine PEEP level with lowest (least injurious) transpulmonary driving pressure during ventilator treatment. The aim of the study during anesthesia in the OR, is to survey lung mechanics in lung healthy and identify patients with lung conditions before anesthesia, which may have an increased risk of postoperative complications.

NCT ID: NCT04356443 Recruiting - COVID-19 Clinical Trials

Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

Start date: April 15, 2020
Phase:
Study type: Observational

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

NCT ID: NCT04236726 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Investigating Health Related Quality of Life in Patients With Chronic Respiratory Failure

CRF-QoL
Start date: December 19, 2019
Phase:
Study type: Observational

To determine the quality of life of patients living with chronic respiratory failure and the impact interventions have on it.

NCT ID: NCT04100616 Recruiting - Obesity Clinical Trials

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity

Start date: March 2, 2020
Phase:
Study type: Observational [Patient Registry]

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding obesity.