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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT04005508 Recruiting - Atrial Fibrillation Clinical Trials

OSA and CV Outcomes in Patients With High Risk AF

POACH
Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

The POACH study is part of the Cardiosleep research program. It is a prospective, observational, multicentre study conducted in Singapore. The recruitment target is 1365 patients. Eligible patients with AF and high cardiovascular risk will be recruited for a home-based sleep study using a FDA-approved portable device. The patients will be divided into 2 groups based on the presence or absence of OSA using apnoea-hypopnoea index ≥ 15 events/hour. The AF will be treated as per local standard practice. Participation in the POACH study will not affect the management of AF. Follow-up will be conducted every 6 months until the median follow-up duration has reached 2 years. The primary endpoint is a four-component composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalisation. Antecubital venous blood samples will be taken from the patients in the morning after the sleep study for targeted mass spectrometry which will measure 83 circulating metabolites. Sparse Principal Component Analysis will be used for data reduction. Identification of distinct associations between metabolic perturbations and OSA will be performed.

NCT ID: NCT04002739 Recruiting - Sleep Clinical Trials

PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome

PROPHET-ACS
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnea (OSA) is a well-known disorder of upper airways collapse during sleep time leading to oxygen desaturation and sleep fragmentation. Despite being increasingly recognized as cardiovascular risk, the effect of OSA on clinical outcomes after Acute Coronary Syndrome (ACS) is not fully defined. Also, OSA syndrome is highly prevalent in ACS and may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea or the intermittent hypoxia could be cardio-protective via the ischemic preconditioning event. Serial sleep studies have shown the progressive reduction of the Apnea / Hypopnea Index (AHI) from the admission in Coronary Care Unit (CCU) to 6 weeks, 12 weeks and 6-month follow up, making necessary to re-assess the severity of OSA after discharge. Therefore, further research in this field is necessary to screen and predict those ACS patients who may experience a change in their AHI index over time.

NCT ID: NCT03995628 Recruiting - Tonsillitis Clinical Trials

Steroids and Pain Control After Tonsillectomy

Start date: December 18, 2018
Phase: Phase 2
Study type: Interventional

This research study aims to find out if a single oral dose of steroid after tonsillectomy will reduce pain and decrease the need for narcotic medications.

NCT ID: NCT03979001 Recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Retinal Vascular Network and Obstructive Sleep Apnea

ORNET
Start date: January 6, 2020
Phase:
Study type: Observational

Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.

NCT ID: NCT03963648 Recruiting - Asthma Clinical Trials

NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP

Start date: September 13, 2019
Phase: N/A
Study type: Interventional

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition resulting in varying degrees of nasal congestion, nasal secretion, facial pain and reduced or absent sense of smell. In Denmark an estimated 200.000 patients suffer from this condition. It affects the quality of life in a degree equivalent to chronic cardiac and respiratory conditions. CRSwNP is known to be associated with inflammation in the nose and sinuses. In some patients the inflammation is also present in the lower airway resulting in shortness of breath, chest constriction, wheezing and coughing. It follows that asthma is often seen in patients with CRSwNP. Even though the association of asthma and CRSwNP is well known it is easy to overlook the asthma further reducing the quality of life. Previous studies have found that undiagnosed asthma is present in about a quarter of patients with CRSwNP. While many of the CRSwNP patients are treated in private ENT practice alone the lack of simple diagnostic tests giving a reliable measurement of airway inflammation is a challenge in diagnosing concurrent asthma. A recent study showed measuring of fractional exhaled nitrogen oxide (FeNO) in exhaled air to be a promising diagnostic test. The concentration of this gas in the exhaled air from the nose and mouth is related to the degree of airway inflammation and can therefore be used as a surrogate measurement in a safe and easy way. With this study the investigators want to measure the concentration of FeNO in patients with CRSwNP in private ENT practices. The aim is to explore if it can be used as a screening test for asthma. The study will also screen the patients for obstructive sleep apnea (OSA). Patients will be recruited from three private ENT practices in the Capital Region of Denmark. Patients with CRSwNP will be recruited from their appointments in the ENT clinics. They will be offered inclusion in the study, and if they give an informed consent, an exhaled NO test and a thorough ENT examination including a fiberoptic examination of the upper airway will be performed. They will also be asked to fill out questionnaires on the severity of symptoms from the nose and lungs, sleep quality and their health in general. Patients will also undergo a sleep study (Cardio-Respiratory Monitoring = CRM) and tests of lung function. With signs of respiratory or sinus disease they will be referred for further investigations and treatment.

NCT ID: NCT03950466 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Real Life Pediatric Obstructive Sleep Apnea

RELIPOSA
Start date: January 1, 2018
Phase:
Study type: Observational

OBJECTIVES: PRIMARY: To analyze the cognitive alterations in children with Obstructive Sleep Apnea OSA in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice. DESIGN: Observational, longitudinal, prospective, and multicenter study.

NCT ID: NCT03948373 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collection will be performed at the beginning of the study and at 3 months.

NCT ID: NCT03942341 Recruiting - Clinical trials for Obstructive Sleep Apnea

Sleep in Adults With Down Syndrome and Alzheimer's Disease

Start date: May 8, 2019
Phase:
Study type: Observational

RATIONALE of the project. Adults with Down syndrome (DS) present severe sleep disorders that are under recognized by caregivers. Aging in DS population increases the prevalence of both Obstructive Sleep Apnea (OSA) and Alzheimer´s disease (AD) dementia at much higher rates than in the general population. AD increases the risk of sleep disturbances and OSA, which in turn worsen cognitive performance and behavioral function. Our hypothesis is that adults with DS and AD dementia will present a higher prevalence of sleep disorders (sleep disruption, sleep circadian disorders and OSA) than in DS without dementia. There are no data evaluating nocturnal sleep in adults with DS with AD dementia. The main objective is to evaluate the prevalence of sleep disturbances in adult subjects with DS and AD dementia, by means of subjective and objectives sleep measures.

NCT ID: NCT03929549 Recruiting - Clinical trials for Obstructive Sleep Apnea

Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. However, limiting factors include incomplete response in some cases, unfavorable facial changes as a result of large advancements, and risk of malocclusion or malunion. This study will be done to determine predictors of success with MMA surgery in patients with moderate to severe OSA. Studies have already shown the value of a remote controlled mandibular positioner (RCMP) device to identify the correct level of therapeutic protrusion needed with oral appliance therapy. Moreover, some patients experience a dose dependent improvement in sleep parameters based on the degree of protrusion during the titration study. Use of RCMP as a means to identify potential candidates for MMA, may help customize treatment options for patients with OSA by providing predictive value.

NCT ID: NCT03924817 Recruiting - Clinical trials for Obstructive Sleep Apnea

Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry

PATT-OSA
Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).