Active clinical trials for "Apnea"

During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep. For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA). The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

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.

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.

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.

Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea. The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.

Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.

Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in children. This was a pilot randomised controlled trial. Patients were randomised to either receive apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome was the duration of safe apnoea, defined as a composite of the time to first event, either time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2 observed during airway management. Secondary outcomes were number of patients whose SpO2 dropped below 95% and number of patients whose SpO2 dropped below 92%.

OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome. Overall objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS). Primary objectives: 1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea. Secondary objectives: Determine the prevalence of OSA in patients who have suffered an episode of ACS. Other secondary objectives will include the effects of CPAP on: To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke. Components of primary composite endpoints Re-vascularization procedures To evaluate all-cause death To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias To evaluate newly diagnosed diabetes mellitus, according to standard definitions To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS)) To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D). To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS. To establish the relationship between CPAP compliance and CV events incidence. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.

The investigators plan to recruit 140 patients (35 subjects in each group) over a period of 18 months in a prospective study of matched/paired case-control subjects across the four groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the 5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP) compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are given the result of the diabetes risk score; 2) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA. The investigators will document that the patients are compliant with CPAP based on review of SD card data recorded by the CPAP machine. Each patient will have serum drawn for the biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist circumference, smoking history, blood pressure, and other standard vital signs will also be collected. There will be no follow-up of the study subjects in groups 3 and 4 and their participation in this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after enrollment to assess whether or not there is any change in CPAP compliance as measured by SD card.

Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.