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Apnea clinical trials

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NCT ID: NCT05881512 Completed - Clinical trials for Obstructive Sleep Apnea

Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).

NCT ID: NCT05868694 Recruiting - Apnea Clinical Trials

A Study of Breathing Sound-based Classification of Patients With Breathing Disorders

Start date: December 1, 2021
Phase:
Study type: Observational [Patient Registry]

Sleep-disordered breathing can damage the cardiovascular system, and may also lead to dysregulation of the autonomic nervous system, endocrine disorders, and hemodynamic changes, causing multi-system and multi-organ damage. Screening for potential central-type patients among patients with respiratory disorders can help provide scientific diagnosis and treatment decisions, thus achieving precise treatment. Currently, research on the identification of sleep-disordered breathing phenotypes is in its infancy. Sleep-disordered breathing phenotypes, such as obstructive and central respiratory events, vary widely among individuals. Compared to indirect methods such as RIP and SpO2, changes in breathing sounds and snoring during sleep can more directly reflect airway obstruction. Different types of sleep-disordered breathing exhibit different characteristics in terms of snoring. Patients with obstructive sleep apnea experience narrowing or blockage of the airway due to relaxation of the throat muscles during sleep, which leads to breathing pauses and hypopnea events, resulting in decreased blood oxygen levels, arousal, and snoring. Central sleep apnea is caused by problems with the brainstem or respiratory control center, leading to breathing pauses. Snoring is usually not very prominent in patients with central sleep apnea. This study aims to screen for potential central-type patients by analyzing upper airway sounds of patients with sleep-disordered breathing, in order to achieve precise treatment.

NCT ID: NCT05846490 Recruiting - Clinical trials for Chronic Kidney Diseases

Impact of Obstructive Sleep Apnea (OSA) Treatment on Blood Pressure Control in Chronic Kidney Disease

Start date: January 8, 2024
Phase: Phase 4
Study type: Interventional

The role of obstructive sleep apnea (OSA) on chronic kidney disease (CKD) is not clear. This randomized clinical trial will test the impact of OSA treatment on blood pressure (BP) and on the estimated glomerular filtration rate (eGFR) in patients with CKD IIIb and IV (eGFR 44-15 ml/min). A polygraph will be performed to assess the presence of OSA (defined by an apnea-hypopnea index ≥15 events/hour). Patients with OSA will be randomized to use continuous positive upper airway pressure (CPAP) or to maintain optimized clinical treatment for BP control. Antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to CPAP follow-up. In addition to clinical (including BP and ambulatory BP monitoring, ABPM) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. Target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. Primary objective: to compare the effect of CPAP on the need to adjust antihypertensive medication to control systolic BP (<130mmHg) in patients with CKD; secondary objectives: 1) to evaluate the reduction in systolic and diastolic BP by office and ABPM; 2) assessment of nocturnal BP dipping; 3) to evaluate the impact of OSA treatment with CPAP on eGFR during follow-up; 4) to evaluate the impact of OSA treatment with CPAP on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR <15ml/min and dialysis); 7) to evaluate the impact of OSA treatment with CPAP on the quality of life of patients with CKD. With a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with OSA per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and CPAP groups will not need to adjust their antihypertensive medication at follow-up, respectively).

NCT ID: NCT05817123 Completed - Clinical trials for Obstructive Sleep Apnea

Validation of the Mutuality Scale in Patients With OSA and Their Partners

VAMOS
Start date: May 10, 2021
Phase:
Study type: Observational

Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated. The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.

NCT ID: NCT05814796 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Assessment of Obstructive Sleep Apnea Syndrome in Non-Obese Patients

Start date: September 1, 2023
Phase:
Study type: Observational

The aim of this study is to evaluate OSAS in non-obese patients, and to compare patient characteristics, clinical markers between obese and non-obese patients.

NCT ID: NCT05814016 Recruiting - Sleep Apnea Clinical Trials

A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery

Start date: May 25, 2023
Phase: Phase 2
Study type: Interventional

The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.

NCT ID: NCT05804084 Recruiting - Clinical trials for Obstructive Sleep Apnea

Patient-centered and Neurocognitive Outcomes With Acetazolamide for Sleep Apnea

PANACEA
Start date: May 16, 2023
Phase: Phase 2
Study type: Interventional

Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure, memory problems and can severely affect quality of life. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Further, its low cost (66¢/day) and once-daily dosing may be attractive for OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations such as studying acetazolamide for only a few days and not capturing important outcomes. The goal of this study is to test if acetazolamide can improve sleep apnea, neurocognitive function and quality of life in adults with OSA, and to assess how it does that. Thus, the investigators will treat 60 OSA patients with acetazolamide or placebo for 4 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 4 week period the investigators will assess OSA severity, neurocognitive function and quality of life. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide. Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments

NCT ID: NCT05795270 Recruiting - Clinical trials for Sleep Apnea Syndromes

Multicenter Study on the Role of Neurodegeneration Biomarkers in Obstructive Sleep Apnea Syndrome With Residual Excessive Daytime Sleepiness.

EDS in OSA
Start date: December 15, 2020
Phase:
Study type: Observational

Excessive daytime sleepiness which still remains after an effective treatment with nocturnal ventilotherapy or with other specific treatments (positional therapy, oro-mandibular devices) in patients with obstructive sleep apnea syndrome has a prevalence of 55% of treated cases, representing a notable theme of clinical and research interest. In recent years there have been several studies on the use of wakefulness-promoting drugs generally prescribed in patients with narcolepsy, in this disorder with promising results. Right in consideration of the forthcoming approval of these drugs, it is important to find biomarkers able to predict which patients will develop daytime sleepiness resistant to ventilatory treatment. Several studies have highlighted the association between obstructive sleep apnea syndrome and the increase of cerebral amyloid beta deposits, concluding that apnoic disorder can be considered a risk factor for the development of cognitive impairment and Alzheimer';s disease. In this scenario, it would be useful to identify biological markers able to underline which clinical phenotypes of sleep apnea syndrome are more associated with residual excessive daytime sleepiness and/or cognitive impairment. In recent years several kits for the assay of biomarkers of neurodegeneration have been developed not only in CSF, but also in human serum. Among them, the most important are light chain neurofilaments (NFL), amyloid isoforms 40 and 42 (Ab40 and Ab42). Other biomarkers found in neurodegenerative diseases associated with excessive daytime sleepiness are orexin A (OXA) and histamine (HA). In this view, the aim of this study is to evaluate the role of biomarkers of neurodegeneration in characterizing disease severity and response to treatment of obstructive sleep apnea syndrome with residual excessive daytime sleepiness.

NCT ID: NCT05758324 Not yet recruiting - Apnea, Obstructive Clinical Trials

Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome

OLIGO-SAS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSA) is defined by the association of clinical symptoms - drowsiness in particular - and sleep breathing disorders, objectified by measuring the apnea-hypopnea index (AHI). Apneas and hypopneas during sleep are responsible for micro-arousals and hypoxemia. In the short term, these result in daytime sleepiness with reduced alertness, difficulty driving and carrying out tasks (increased risk of road accidents and accidents at work), memory and concentration problems. , mood disorders. These disturbances lead to an impairment of the quality of life. In the long term, severe OSA (AHI > 30 events/hour) increases all-cause mortality and cardiovascular morbidity. The reference treatment is nasal ventilation by Continuous Positive Airway Pressure (CPAP). In practice, the observance and effectiveness of CPAP are limited by the sometimes difficult acceptance of cumbersome equipment, involving noise pollution and requiring the wearing of night-time equipment that some patients find difficult to bear. The alternative treatment is represented by the mandibular advancement orthosis . Lifestyle and dietary measures are always recommended. To date, no pharmacological treatment has demonstrated its effectiveness in OSA. Studies have shown that the antioxidant capacity of the blood is reduced in patients with OSA. It would be secondary to the cycles of hypoxia and reoxygenation which cause a modification of the oxidative balance, leading to an increase in free radicals. It has been observed that the serum levels of trace elements and heavy metals are higher during OSA, by deterioration of the balance of these substances due to oxidative stress and inflammation. Antioxidant therapies have reduced biomarkers of oxidative stress in apneic patients. A new path of research is opening up with the use of antioxidants and trace elements in OSA. To scientifically support the hypothesis of the action of these supplements based on trace metals on OSA, PRONUTRI wish to conduct a comparative, randomized, double-blind study versus placebo evaluating the effect of a specific complex of trace metals in the OSA.

NCT ID: NCT05746338 Recruiting - Clinical trials for Obstructive Sleep Apnea

Validation of a Ring-type Wearable Device

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Study name: Validation of a Ring-type Wearable Device for Blood Oxygen Monitoring and Obstructive Sleep Apnea Syndrome Screening in Adult Chinese. Objective: 1) To examine the accuracy of blood oxygen monitoring assessed via a ring-type wearable device in comparison to traditional finger clip pulse oximeter; 2) To assess the agreement between the ring-type wearable device and PSG monitor on OSAS screening. Study design: Clinical diagnostic trial. Study population: Individuals who are willing to participate in the study and sign the informed consent are considered to be eligible. Specific inclusion criterias include: 1) Agree to receive overnight polysomnography and wear the ring-type device at the same time; 2) At least 18 years old. Sample size estimation: About 200 participants. Timeline: Start of subjects' enrollment: Dec 2022; End of subjects' enrollment: Oct 2023; End of study: Oct 2023. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.