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Respiration Disorders clinical trials

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NCT ID: NCT06229600 Recruiting - Respiratory Disease Clinical Trials

REspiratory reHABilitation and PSYchiatric Comorbidities

REHABPSY
Start date: January 2, 2024
Phase:
Study type: Observational

Patients with respiratory insufficiency, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, asthma, bronchiectasis, and, to a lesser extent, other pathologies that result in respiratory insufficiency and require rehabilitation are admitted to in-hospital Respiratory Rehabilitation. Several studies have assessed the impact of comorbidities in the most frequent respiratory diseases such as COPD, asthma, pulmonary fibrosis, and cystic fibrosis in terms of worsening mortality, morbidity, and disease progression. However, to our knowledge, there is no reliable quantification in Italy of the percentage of the presence of mental disorders (psychiatric/neurodegenerative) according to the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 classification in respiratory patients as well as the prevalence of mental disorders present among patients requiring in-hospital rehabilitation programs. The study hypothesizes that these disorders are present among patients admitted to rehabilitation centers and that they may impact the final rehabilitation outcome.

NCT ID: NCT06220019 Not yet recruiting - Clinical trials for Community Acquired Pneumonia

REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)

Start date: April 2024
Phase:
Study type: Observational

The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with CAP after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

NCT ID: NCT06197646 Recruiting - Respiratory Disease Clinical Trials

Inhalation Therapy and Therapeutic Play

INHALATION
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The aim of this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in children. The hypotheses it aims to answer are as follows: H1: Inhalers given using a mask with a cartoon character facilitate treatment compliance. H2: The inhaler given using a mask with a cartoon character makes treatment compliance difficult. H3: Inhaler treatment using a mask with a cartoon hero increases parental satisfaction. H4: Inhaler treatment using a mask with a cartoon hero decreases parental satisfaction. H5: Inhaler treatment using a mask with a cartoon hero has a positive effect on the hospitalization process. H6: Inhaler treatment using a mask with a cartoon hero has a positive effect on the recovery process. H7: Compared to routine inhaler mask use, the use of masks with cartoon heroes provides a positive relationship between treatment adherence and parental satisfaction. In the study, according to randomization, the intervention group will receive inhalers with masks, and the other group will receive inhalers routinely used in the clinic. The treatment of the children was planned by the physician, and no additional treatment was given for the study. Children's adherence to treatment and parents; satisfaction will be evaluated. The effectiveness of the masked inhaler used will be asked.

NCT ID: NCT06170827 Active, not recruiting - Respiratory Disease Clinical Trials

Study to Evaluate the AIO-001 in Healthy Participants

Start date: December 1, 2023
Phase: Phase 1
Study type: Interventional

This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.

NCT ID: NCT06156462 Completed - Pneumonia Clinical Trials

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Adolescent and Adult Patients in an Emergency Department

Start date: January 1, 2024
Phase:
Study type: Observational

Aim is to to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of respiratory disease in the study's clinical setting compared to a clinical adjudication committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for respiratory disease diagnosis in an emergency department. Eligible subjects will be consented/enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF). The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0 diagnoses. Additional medical information will be collected from the treating team, from the subject and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a clinical adjudication committee (CAC) will determine the final clinical diagnosis using the disease case definitions, eCRF data and the subject's medical record. Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed. The blinded ResAppDx v2.0 diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0 diagnoses compared to agreement with the CAC's final clinical diagnoses.

NCT ID: NCT06156436 Completed - Pneumonia Clinical Trials

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department

Start date: January 1, 2024
Phase:
Study type: Observational

Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.

NCT ID: NCT06153485 Recruiting - Clinical trials for Chronic Respiratory Disease

Automated Titration for Home Oxygen Therapy

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Patients with chronic respiratory disease may be prescribed oxygen therapy. Currently, the dose of oxygen flow is fixed (FixedO2) depending on activity level i.e. rest, physical activity and sleep. Automated Titration of Oxygen (AutoO2) is a closed-loop system in which the oxygen flow to the patient is continuously machine adjusted to meet the patient's immediate needs on the basis of signals from pulse oximetry (SpO2). The purpose of this study is to examine if automated oxygen control based on pulse oximetry provided to participants is superior to prescribed fixed oxygen flow in keeping SpO2 within the intended target interval of 92 to 96% arterial oxygen saturation.

NCT ID: NCT06149494 Recruiting - Copd Clinical Trials

RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.

NCT ID: NCT06148194 Recruiting - Respiratory Disease Clinical Trials

Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. In recent years, preventive strategies for respiratory inflammation have garnered increasing attention, with probiotics being shown to have the potential to support treatment and prevention & reduce the risk of recurrent respiratory infections, thus decreasing reliance on antibiotics. Here, the investigators propose that direct nasal spraying of probiotics may be safe and effective in preventing respiratory diseases. The aim of the study is to evaluate the effectiveness of two types of nasal- praying Bacillus probiotics including LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases. Study Population: The sample size is 600. Description of Sites: The study is conducted at preschools in Son Tay Province, Hanoi, Vietnam. Description of Study Intervention: A total of 600 eligible children are randomly divided into three groups (n = 200/group each). Children in the Control group received 0.9% NaCl physiological saline twice daily (morning and afternoon), with 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time), continuously for four weeks. Children in the Probiotic 1 group receive LiveSpo Navax product, and children in the Probiotic 2 group receive LiveSpo Navax Kid, with the same dosage and frequency as the Control group. Study Duration: 12 months.

NCT ID: NCT06142513 Not yet recruiting - Obesity Clinical Trials

The Effect of Obesity Hypoventilation Syndrome on Exercise Capacity, Peripheral Muscle Strength, and Quality of Life in Obese Individuals

Start date: April 10, 2024
Phase:
Study type: Observational

Obesity Hypoventilation Syndrome(OHS) is a disease characterized by daytime hypercapnia and sleep-disordered breathing without other causes of hypoventilation in individuals with a body mass index above 30 kg/m2. Sources state that obesity is at the basis of the metabolic changes seen in individuals with OHS. Obesity, together with cardiovascular system complications, lung volumes, work of breathing and sleep quality, creating the basis for respiratory problems. In addition, sedentary lifestyle habits, which are common in obese individuals, cause negative effects on exercise capacity and peripheral muscle strength. It has been shown in the literature that decreased exercise capacity due to obesity strongly interacts with the risk of all-cause mortality. As a result of obesity and all this negative picture, impaired emotional state and decreased quality of life are observed in individuals. Numerous studies have shown that obese individuals generally have a low level of physical activity, there is a decrease in peripheral muscle strength, obese individuals are at risk for sleep-related respiratory problems and health-related quality of life is often negatively affected in obese individuals. With these studies, the effects of obesity on individuals have been evaluated with objective evaluation methods. However, the same cannot be said for OHS. It is not clear how exercise capacity, peripheral muscle strength and quality of life parameters, which are known to be negatively affected by obesity, are affected in individuals with OHS. Based on this point, this study aims to investigate whether OHS has an additional effect on exercise capacity, peripheral muscle strength and quality of life in addition to obesity.