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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03627169 Completed - Clinical trials for Obstructive Sleep Apnea

PSG Validation of MATRx Plus AHI

Start date: July 25, 2017
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs. Almost thirty years ago, initial population studies found the prevalence of OSA to be five to nine percent of the adult population. Excess body weight is a risk factor for the development of OSA, and the recent rise in prevalence of obesity has led to revised estimates of OSA prevalence, now at seventeen per cent of the adult population. OSA is poorly recognized clinically; 85% of apneics remain undiagnosed and untreated. Currently, the diagnosis of OSA commonly relies on an overnight, in-hospital polysomnogram (PSG). Due to the extensive attachments to the body surface required in a PSG, it has developed a negative impression. Any effective solution to the public health challenges posed by sleep apnea will have to consider the need for less cumbersome and off-putting methods. Zephyr Sleep Technologies has developed a device that has been approved for use in Canada. The MATRx plus device functions as both a Level III sleep recorder (records respiratory airflow, respiratory effort, pulse rate, and arterial oxygen saturation) as well as a home-based system to select patients for oral appliance therapy. The American Academy of Sleep Medicine (AASM) recommends the use of apnea-hypopnea index (AHI) for the diagnosis and categorization of OSA severity. The Level III function of the MATRx plus device is approved for use in Canada with two autoscoring methods: oxygen desaturation index, ODI and apnea-hypopnea index, AHI, but requires further validation of AHI for clearance by the US Food and Drug Administration (FDA). The proposed research will validate the AHI autoscoring function of the MATRs plus Level III home sleep recorder by comparing it to data recorded in a PSG, which is considered to be the gold standard for sleep testing. Though the effectiveness of the AHI autoscoring algorithm has been previously established, it has not been validated against PSG data. Additionally, other parameters such as snoring will be examined in order to develop scoring algorithms for other facets of sleep disordered breathing.

NCT ID: NCT03616327 Completed - Clinical trials for Obstructive Sleep Apnea

Workflow Validation of an In-Home Feedback Controlled Mandibular Positioner

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to test the workflow of the MATRx and MATRx plus feedback controlled mandibular positioner in its intended setting and considerations related to decision making by the care provider. The workflow includes the participant's recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests.

NCT ID: NCT03605485 Completed - Clinical trials for Obstructive Sleep Apnea

The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Start date: August 7, 2018
Phase: N/A
Study type: Interventional

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

NCT ID: NCT03603678 Completed - Clinical trials for Sleep Apnea, Obstructive

Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor

SANDMAN
Start date: August 13, 2018
Phase: Phase 2
Study type: Interventional

The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients.

NCT ID: NCT03600246 Completed - Clinical trials for Obstructive Sleep Apnea

Prospective Observational Registry for Obstructive Sleep Apnea in Patients With Acute Myocardial Infarction

OSAAMI
Start date: June 11, 2018
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) has been known as a risk factor for coronary artery disease, heart failure, cerebrovascular accident and atrial fibrillation. One study reported that patients with OSA have more atherosclerotic plaque burden in intravascular ultrasonography examination. Among patients who admitted with acute myocardial infarction (AMI), 65.7% (69 of 105) patients were diagnosed with OSA. Other long-term follow-up study revealed that 45.4% of patients (594 of 1311) who performed percutaneous coronary intervention (PCI) were diagnosed with OSA. Moreover, the OSA group was a significant independent predictor of major adverse cardiac and cerebrovascular events (MACCEs). Polysomnography (PSG) is the gold standard for the diagnosis of OSA. But, PSG is expensive, time-consuming and difficult to perform immediately. Recently, a portable device named WATCH-PAT (Itamar Ltd, Israel) was developed for the diagnosis of OSA. Validation study demonstrated a high correlation between WATCH-PAT and PSG in apnea-hypopnea index, lowest oxygen saturation and sleep time. This result suggested WATCH-PAT can be performed as an alternative or supportive device of PSG. WATCH-PAT. The portable device also can be useful to detect OSA in bus drivers who can be the reason for public traffic accidents. Moreover, WATCH-PAT can be applied to assess postoperative improvement of OSA. Although OSA is known as one of the risk factors for cardiovascular disease, there is a lack of evidence to recommend of the evaluation of sleep disorder in patient with coronary artery disease. Awareness and compliance for OSA are very low in both patients and cardiologists. Active diagnosis and treatment are definitely needed. Therefore, the primary endpoint of this study is to evaluate the prevalence of OSA in AMI patients who treated PCI. The secondary endpoint is to evaluate the 1-year incidence rate of MACCEs according to the presence or absence of OSA.

NCT ID: NCT03592108 Completed - Clinical trials for Obstructive Sleep Apnea

Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.

Start date: July 30, 2018
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) syndrome affects 40-60% of patients presenting with cardiovascular diseases. Cheyne-Stokes respiration is a type of central apnea characterised by the presence of at least three consecutive episodes of apnea and/or hypopnea separated by a crescendo-decrescendo variation of the breathing amplitude with a cycle length ≥ 40 seconds and a central apnea/hypopnea index ≥ 5/h, for at least two hours of recording. The association between heart failure and Cheynes-Stokes respiration is known and a recent study showed that Cheynes-Stokes respiration was associated with more severe heart failure. Moreover, a medical and medical/financial benefit of the early detection of cardiac decompensation has been reported. The purpose of this feasibility study is to investigate the benefit of Cheyne-Stokes respiration remote monitoring in CPAP-treated patients with OSA for the early detection of significant cardiac events (heart failure, rhythm disorder, diastolic dysfunction). To achieve this aim, a modified approach of CPAP remote monitoring is proposed based on the performance of the latest generation of positive pressure devices from ResMed, AirSense™ 10 Autoset™, which can detect and record the presence of Cheynes-Stokes respiration. For a period of 12 months, in addition to the usual daily remote monitoring (CPAP adherence, pressure settings, level of air leakages), the healthcare provider will systematically monitor the CSR data whenever the AHI increases significantly. Physicians will be alerted when a CSR occurs and they will see the patients within a short time for pulmology and cardiology consultations in order to screen the onset of significant cardiac event. After the 12-month period of modified remote monitoring, the telemedicine returns to the usual procedure. Patients who had at least one CSR occurrence during the first 12-month period will be followed up to 24 months to assess their medical condition.

NCT ID: NCT03591250 Completed - Clinical trials for Obstructive Sleep Apnea

Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)

OBSERVE
Start date: December 7, 2018
Phase:
Study type: Observational

Health care renunciation is a factor that can alter patients' health status and increase the costs of its support. To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes. The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance. The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ). The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

NCT ID: NCT03589417 Completed - Clinical trials for Obstructive Sleep Apnea

Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea

Start date: September 24, 2018
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a clinical condition characterized by the repetitive obstruction of the upper airway during sleep, resulting in nocturnal hypoxaemia and fragmented sleep. Fragmented sleep leads to daytime sleepiness that causes alterations in reaction times and reflexes . Postural stability is an important function of the human body. It is shown that the sleep deprivation disturbs daytime postural stability and balance. Aim of this study is to examine the influence of OSA severity and daytime sleepiness on postural stability, balance and fall risk.

NCT ID: NCT03579225 Completed - Clinical trials for Obstructive Sleep Apnea

Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus

Start date: July 1, 2018
Phase:
Study type: Observational

Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and pulls the lower jaw forward, opening the airway and allowing normal breathing. Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies invented a device that tests various positions of the lower jaw from the comfort of your own home. The MATRx plus device is considered investigational since it has not been cleared by the U.S. FDA. During the MATRx plus test, the patient sleeps with a motorized positioner that moves the lower jaw. Jaw movement is automatically controlled by a computer, making the device a feedback controlled mandibular positioner. The purpose of the study is to test the workflow of the MATRx plus feedback controlled mandibular positioner in its intended setting. The workflow includes recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests. The main objective is to determine the turnaround time of a MATRx plus test in a real-use dental setting.

NCT ID: NCT03575143 Completed - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV

PLWH/OSA
Start date: August 2, 2018
Phase:
Study type: Observational

The investigators seek to understand how the different underlying causes of OSA affect the way people living with HIV (PLWH) experience OSA. The investigators also want to understand how symptoms of obstructive sleep apnea improve with treatment, and if this too, is affected by the underlying cause of OSA in that individual