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Apnea clinical trials

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NCT ID: NCT02788149 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Ultrasound Against Obstructive Sleep Apnea

Start date: June 2016
Phase: N/A
Study type: Interventional

To investigate the accuracy of neck ultrasound in identifying and discriminating the severity of obstructive sleep apnea (OSA). Primary objective: To test the hypothesis that ultrasound can be used as a reliable tool for identifying the anatomic characteristics and dynamic changes of pharyngeal airspace in patients with OSA. Secondary objective: Investigate if ultrasound can be used to discriminate OSA severity. The investigators will compare these results to the results from polysomnography study.

NCT ID: NCT02717585 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Effect of CPAP on Symptoms of Patients With Fibromyalgia and Obstructive Sleep Apnea

FM-OSA
Start date: December 2018
Phase: N/A
Study type: Interventional

Fibromyalgia (FM) is a chronic pain disorder associated with a wide spectrum of sleep disorders. In fact, insomnia and waking unrefreshed are currently considered part of the criteria for diagnosis. Recent studies show that sleep quality and symptoms of FM are inversely correlated. Obstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway. Nonrestorative sleep and fatigue are common symptoms of FM and OSA and may suggest related pathophysiology or co-morbidity that is yet to be diagnosed. This prospective randomized controlled clinical trial will enroll adult FM patients who screen positive for OSA by the STOP-Bang questionnaire. OSA will be confirmed by a laboratory polysomnography (PSG) study. After undergoing further baseline questionnaires and investigations, patients confirmed to have FM with moderate to severe OSA will be randomized to one of two different treatments: 1) Treatment for FM at the Chronic Pain Clinic together with Continuous Positive Airway Pressure (CPAP) devices for their OSA OR 2) Control group receiving treatment for FM at the Chronic Pain Clinic only.

NCT ID: NCT02699138 Withdrawn - Clinical trials for Sleep Apnea, Obstructive; Post-Traumatic Stress Disorders

Obstructive Sleep Apnea and Arousal Threshold in Patients With Post-traumatic Stress Disorder

Start date: October 2021
Phase: Early Phase 1
Study type: Interventional

Obstructive sleep apnea (OSA) has traditionally been attributed only to a collapsible upper airway. However, it is increasingly recognized that multiple additional non-anatomical mechanisms contribute to the disease. Higher rates of OSA in patients with post-traumatic stress disorder (PTSD) than in those without PTSD have been reported however the mechanism behind this increased prevalence has not been investigated. Our hypothesis is that patients with PTSD have a predisposition to OSA due to a lower respiratory arousal threshold (wake up too easily) than patients without PTSD. The goal of this project will be to study and compare the ArTH in patients with PTSD and those without. In addition, we plan to see whether medications can be used to increase the arousal threshold and treat OSA in patients with PTSD.

NCT ID: NCT02685579 Withdrawn - Sleep Apnea Clinical Trials

The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo

OSATDV
Start date: June 2016
Phase: N/A
Study type: Observational

Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.

NCT ID: NCT02645942 Withdrawn - Clinical trials for Obstructive Sleep Apnea

L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea

CARNIMET
Start date: August 2020
Phase: N/A
Study type: Interventional

The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.

NCT ID: NCT02559427 Withdrawn - Clinical trials for Obstructive Sleep Apnea Syndrome

SPA Therapy in the Treatment of Sleep Apnea Syndrome

THERMA-SAS
Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

NCT ID: NCT02557412 Withdrawn - Sleep Apnea Clinical Trials

Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

Start date: May 2015
Phase: N/A
Study type: Interventional

OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA). Secondary objectives: - Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA. - Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA. DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment. STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics. Sample size. 38 patients who completed the test in each treatment arm. TREATMENT Patients will be randomized to one of the following treatment arms form: 1. hygiene and dietary recommendations. 2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control). 3. Treatment with positive airway pressure (CPAP). ENDPOINTS: Efficacy endpoints. - Primary endpoint: LDL-cholesterol. - Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP). - Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin). - Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH). - Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ). Security endpoints. - Notification of clinical adverse events. - Compliance with CPAP (average hours use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT02426424 Withdrawn - Stroke Clinical Trials

Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients

Start date: January 2018
Phase: Phase 4
Study type: Interventional

This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation. The study will enroll 140 subjects which will be randomized into one of two arms: - Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge. - Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.

NCT ID: NCT02408328 Withdrawn - Apnea Clinical Trials

Management of Apnea in Late Preterm and Term Infants

Start date: June 2020
Phase: Phase 2
Study type: Interventional

Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it is relatively more common in extremely premature infants, it also occurs frequently in late preterm and even full term infants. Since the majority of all births include late preterm infants and full term infants, the absolute number of late preterm and full term infants with apnea remains significant. Evidence-based guidelines for the management of apnea in such infants do not exist. Current management falls into two distinct but very different categories. This study will compare these two distinct management strategies. Our study will be a prospective, randomized pilot trial to provide data regarding (a) feasibility for recruitment and study protocols and (b) provide preliminary data regarding efficacy of both treatment arms. Our primary objective will be to test the hypothesis that early discharge and outpatient monitoring of late preterm and term infants with apnea of prematurity results in decreased length of hospital stay, is safe, and results in improved patient satisfaction, as assessed by the PedsQL questionnaire and Impact on Family Scale. Our study population will include infants who meet the following criteria: (1) Born at greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea, bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that apnea/bradycardia/desaturation remains the final discharge issue for at least 7 days. Infants enrolled in this research study will be randomized to in hospital observation versus early discharge home with caffeine and a home monitor. Neither strategy is experimental as both are currently utilized by neonatologists locally and nationally. A direct comparison of the two treatments, however, has never been undertaken in a study. If an infant is assigned to the in hospital group, they will remain in the hospital until an apnea free period of at least 5 consecutive days has been established. Outpatient follow up will occur per unit standard and typically includes a nursing visit and a doctor visit within 2-3 days of discharge. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1 month after hospital discharge, and at 6 months of age. Each questionnaire will ask about topics such as satisfaction with hospital stay, quality of life, and numbers of acute care visits and/or rehospitalizations. Alternatively, if an infant is assigned to the early discharge group, caffeine will be given to the infant and if after a 3 day period no further apnea is noted the infant will be discharged home with continued daily caffeine therapy by mouth as well as a home monitor. Caffeine is a very commonly used drug in neonates and has an excellent safety profile. Side effects are minimal and may infrequently consist of gastroesophageal reflux. All caregivers will receive training on the use of a home monitor. Initial outpatient follow up will occur per unit standard and typically includes a nursing visit and a doctor visit within 2-3 days of discharge. Additionally, caregivers will be contacted via telephone within 2 days to answer any questions or address any concerns pertaining to apneic events, home monitor use, or caffeine therapy. Follow up in the pulmonary clinic will be arranged at 42-43 weeks gestational age at which time caregivers will be taught to determine the baseline frequency of monitor alarms on caffeine. At 43 weeks corrected gestational age, caregivers will be instructed to discontinue caffeine therapy and advised to contact the pulmonary clinic should alarm frequency increase. An outpatient recorded oximetry study will be arranged at least 1 week after discontinuation of caffeine therapy. Home pulse oximetry monitoring will be discontinued if no significant events are recorded. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1 month after discontinuation of the home monitor, and at 6 months of age. Each questionnaire will ask about topics such as satisfaction with hospital stay, quality of life, and numbers monitor alarms, acute care visits and/or rehospitalizations.

NCT ID: NCT02356367 Withdrawn - Heart Failure Clinical Trials

French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)

FACE
Start date: May 2016
Phase: N/A
Study type: Observational

The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.