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71 active trials for Sleep Apnea

Corneal Sensitivity in Patients With Sleep Apnea Syndrome

This study is a prospective, single center clinical trial to assess corneal sensitivity and nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to participate in the study. After execution and review of the consenting procedures, a detailed history will be taken and a slit lamp examination performed, verifying ocular health. This consists of an examination of both eyes including assessments of ocular lids, lashes, cornea and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope allows for high resolution imaging of the nerve plexus under the corneal epithelium. This corneal nerve plexus is responsible for corneal sensitively and changes or loss have been established as an early, sensitive indicator of corneal neuropathy. The investigators anticipate that this study will require approximately 30 patients for each group and will last approximately 12 months for recruitment and completion of subject visit phases. There is only one clinical visit designed for this project, unscheduled visits may be scheduled in case of an adverse event. Patient recruitment will be complete at the one-year time point. At the 14 month time point, all data points will have been collected and assessment of the outcome measure (corneal sensitivity in sleep apnea patients versus control patients) will be complete.

Start: July 2015

Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean. An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Start: May 2021

Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea

The aging process tends to promote an overall increase in inflammation compromising the immunologic system regulation, sleep/wakefulness pattern, and neurocognitive performance. In elders, there is an increase in repetitive arousals during sleep, secondary to breathing interruption by pharynx collapse, generating a transient reduction in oxygen delivery to the brain known as obstructive sleep apnea. This lack in oxygen supply results in an inflammatory process producing brain damage. Some substances present in the blood seem to be associated to neurocognitive damage, like S100? protein, cortisol, interleukin 1-?,6 and TNF-?. In the other way, a substance called brain-derived neurotrophic factor (BDNF) enhances cognitive function, and memory consolidation improvement.

Start: August 2019

Addressing Insufficient PAP Use in Older Veterans

Sleep apnea is a common problem in middle-aged and older Veterans that is associated with poor nighttime sleep, more daytime sleepiness, poor functioning and worse quality of life. The recommended therapy for most patients with sleep apnea is positive airway pressure (PAP) therapy; however, over time many patients prescribed PAP therapy no longer use it regularly. This study will test the effects of an education program specifically designed for middle-aged and older Veterans who have stopped using their PAP device, or are not using it regularly. Eligible Veterans who are enrolled into the study will receive a baseline assessment that includes questionnaires about sleep, health, and quality of life. After completing the baseline assessment, participants will be randomly assigned to one of two education groups. Both groups will meet individually with a "sleep coach" for 5 session over 8 weeks, then they will be contacted monthly by telephone for up to 6 months. Participants will complete follow-up assessments immediately after the fifth education session and again at 6-months and 12-months. If successful, this approach has the potential to improve sleep, function and quality of life in middle-aged and older Veterans.

Start: October 2021

Do Endotypes Predict Response and Sequelae in OSA Patients

This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.

Start: June 2021

Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI

This clinical trial will examine the efficacy of continuous positive airway pressure (CPAP) therapy in improving psychosocial, neurocognitive and behavioral consequences of moderate-to-severe sleep-related breathing disorders (SRBDs) in people living with spinal cord injury (SCI).

Start: September 2019

Technology-Supported Treatment of Sleep Apnea in Prediabetes

Despite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.

Start: November 2020

Cross-sectional Study on a Given Day Within the Paris Saint-Joseph Hospital Group

Sleep apnea syndrome has an estimated incidence of 2 to 4% in the adult population and more so in men and with aging. It is an independent risk factor for mortality. Cardiovascular pathologies, diabetes, and stroke are known comorbidities with a high rate of association. There is no recommendation to screen these patients although the interest is assumed and sleep apnea syndrome is largely underdiagnosed. Interrogation and clinical examination guide but they are neither sensitive nor specific. The use of scores improves screening. In the general population, the Berlin score has a high false negative rate. The STOP-BANG score is sensitive but with a poor positive predictive value. Combined, these scores can be used to detect Sleep Apnea Syndrome. The interest of a management was especially shown for the very symptomatic syndromes because it is a pledge of observance of the treatment, itself necessary for the effectiveness in the prevention of the cardiovascular complications.

Start: August 2021

Global SYMPLICITY Registry

This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension and gathering data for other diseases characterized by elevated sympathetic drive, such as diabetes mellitus type 2, renal insufficiency, etc. The Global Symplicity Registry will consecutively enroll 3000 patients who undergo the renal denervation procedure, from over 200 sites worldwide.

Start: February 2012

SAMPAP Trial -Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence

This randomized controlled trial will evaluate people who have moderate-to-severe obstructive sleep apnea (OSA), and have been newly prescribed a Positive Airway Pressure (PAP) machine. Patients with suboptimal adherence, defined by the Center of Medicare and Medicaid criteria (<70 % usage and <4 hours of average daily PAP usage) will be identified. The purpose of this research is to examine the impact of the sleep apnea management (SAM) grouped based-intervention on positive airway pressure adherence and patient report outcomes questionnaires (quality of life, daytime sleepiness and depressive symptoms) and PAP barrier questionnaire compared to a patient group managed by regular non-sleep prescribing provider.

Start: April 2019

Treating Sleep Apnea in Women Veterans

This study is a randomized controlled trial (RCT) to test two sleep apnea education programs for women Veterans newly diagnosed with sleep apnea (SA) who are prescribed positive airway pressure (PAP) therapy. This education program is designed to improve participants' sleep quality and help them to adjust to PAP therapy. Participants will undergo a sleep and health assessment that will be performed prior to beginning the education program. This assessment includes wearing a wrist actigraph to measure sleep and wake periods for 7 days and nights, and answering questionnaires about sleep habits and health. Participants will be randomly assigned to one of two 6-week education programs provided by a study interventionist. Follow-up sleep and health assessments will be conducted at the end of the 6-week education program and 3-months later. PAP usage data will be collected remotely for 12 months from PAP therapy initiation.

Start: June 2018

Sleep for Stroke Management and Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Start: May 2019

Selected Disorders and Sleep Bruxism

Sleep apnea is a common and serious health problem in the Polish population. According to epidemiological data problem concerns about 7% of the adult population. The most common sleep disorder is obstructive sleep apnea (OSA). The consequence of episodes of airway obstruction and sleep fragmentation is an inefficient sleep, pathological daytime sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or throttling. The direct consequences of sleep apnea are hypoxia, increased heart rate and increased blood pressure. Frequent complications of OSA are hypertension, stroke, cardiac arrhythmia, coronary artery disease and pulmonary hypertension. An additional problem in patients with sleep apnea is an increased incidence of bruxism. Bruxism is a common problem; reports of prevalence range from 8-31% in the general population. The most common symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain and headaches. The etiology of bruxism is multifactorial and not fully understood. It can be caused by biologic, psychologic and exogenous factors. Arousals during the apnea episodes are considered to be a major cause of sleep bruxism in OSA patients. The relationship between OSA and sleep bruxism is still not clearly defined. Further research is needed to help explain the relationship between these two phenomena, which will enable further therapy in patients with coexisting OSA and sleep bruxism (SB).

Start: April 2017

Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV). Currently, we do not have long-term follow-up data for these patients. The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire. Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Start: January 2021

Football Players Health Study In Person Assessments Study

The aim of the Football Players Health Study (FPHS) is to advance the understanding of the complex and inter-related pathways that can develop into player related illness and disability. Former National Football League players will be given the opportunity to undergo 2&1/2 days of rigorous assessment in the areas of Cardiac Dysfunction, Neurocognitive Disease, Chronic Pain, and Sleep Apnea to attempt to define the pathology among former professional athletes.

Start: April 2019

Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.

Start: May 2010

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study will answer the following questions: Does ongoing, repeated-dose administration of atomoxetine-plus-oxybutynin (referred to as "AtoOxy") improve OSA severity, and do patients exhibit signs of symptomatic relief? Most importantly, which phenotypic subgroup of patients preferentially benefit from this intervention?

Start: September 2019

Obstructive Sleep Apnea and Glucose Metabolism

Many adults who are overweight have obstructive sleep apnea (OSA) which disrupts sleep and makes it difficult to breath during the night. OSA increases the risk for a person to become insulin resistant and diabetic. It is not known why OSA causes this problem, i.e., whether it is disrupted sleep or lack of oxygen., which can change how the body handles glucose in adipose tissue, muscle tissue and liver. The purpose of this research study is to determine the key issues and mechanisms responsible for dysregulated glucose metabolism in people with OSA. The investigators will do this by comparing glucose metabolism in people who have OSA, and those who do not, and by evaluating the effect of treating OSA by providing continuous positive airway pressure (CPAP) or simply oxygen during the night. The proposed study will evaluate the primary causes(s) (hypoxia, sleep fragmentation, or both) and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities. Knowing the primary cause of Obstructive Sleep Apnea and pathophysiological mechanisms responsible for the OSA-associated metabolic abnormalities could help develop potentially novel therapeutic strategies to provide treatment for adults in improving OSA and associated comorbidities.

Start: January 2018

The Brain Changes in Sleep Apnea Study

Sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. However, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. The Brain Changes in Sleep Apnea Study will look at the brain health of people with severe sleep apnea both before and after 4 months of treatment with a CPAP machine. Pre- and post-CPAP treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and urine tests, a pulse wave velocity test, and an MRI. Also pre- and post-CPAP treatment, participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for 8 nights to track the duration and quality of their sleep, and wear a device for 1 night of sleep to assess their breathing and blood oxygen levels. It is expected that there will be improvements in participants' brain health after 4 months of CPAP treatment.

Start: December 2018

Non-contact Sleep Apnea Identification in Neurological Rehabilitation

To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients. The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic. The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.

Start: April 2021