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OSA clinical trials

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NCT ID: NCT03336515 Completed - OSA Clinical Trials

Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)

POSTURAL
Start date: September 1, 2015
Phase: N/A
Study type: Interventional

The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).

NCT ID: NCT03196583 Completed - Clinical trials for Obstructive Sleep Apnea

Efficacy of a Novel MAD in OSA

BVL Project
Start date: May 10, 2017
Phase: N/A
Study type: Interventional

Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. The most commonly used OA reduces upper airway collapse by advancing the mandible (mandibular advancement devices, MAD). There is a strong evidence base demonstrating that MADs improve OSA in the majority of patients, including some with more severe disease. However, MADs are not efficacious for all, with approximately one-third of patients experiencing no therapeutic benefit. Patients often prefer MADs to gold-standard CPAP treatment. Head-to-head trials confirm CPAP is superior in reducing OSA parameters on polysomnography; however, this greater efficacy does not necessarily translate into better health outcomes in clinical practice. Comparable effectiveness of MADs and CPAP has been attributed to higher reported nightly use of MADs, suggesting that inferiority in reducing apnoeic events may be counteracted by greater treatment adherence. The MAD in study, called Bite-Velo Linguale (BVL), features a novel monobloc device including a tongue retainer, a suction cavity that maintains the tongue down onto the mouth floor in order to prevent it from raising towards the hard palate, and therefore increasing the retro lingual aerial space. Its design requires the presence of only four occlusal points, allowing for a direct anchorage onto the mandibular bone, thus reducing the risk for occlusal changes, tooth loosening and the development of an anterior cross bite, which represent some of the major long-term adverse effects of oral appliances. MADs are generally well tolerated, although short-term adverse effects during acclimatization are common. Long-term dental changes do occur, but these are for the most part subclinical and do not preclude continued use. The BVL in study features technological advances aimed at preventing long-term dental changes, as well as improving tolerability and easiness of use.

NCT ID: NCT03172130 Completed - OSA Clinical Trials

Sham CPAP vs. Straight CPAP for Chronic Cough

Start date: October 13, 2014
Phase: N/A
Study type: Interventional

Chronic cough is an important clinical problem in primary care and sub-specialty practice. Besides the distress experienced by patients with chronic cough, significant healthcare resources are expended to understand the role of gastroesophageal reflux, asthma and post-nasal drip in understanding their contribution to cough. Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly, treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough includes beneficial effects on reflux and airway inflammation. The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in chronic cough patients improves cough. While these patients with chronic cough are not routinely screened and treated for OSA, this study aims to evaluate these chronic cough patients with screening questionnaires for OSA and if necessary with polysomnography and randomize them to either CPAP or sham CPAP for 6 weeks.

NCT ID: NCT03051724 Completed - OSA Clinical Trials

Telemedicine for CPAP Therapy Control in OSA

Start date: February 6, 2017
Phase: N/A
Study type: Interventional

Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies. As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's. The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.

NCT ID: NCT02856633 Completed - Hypertension Clinical Trials

Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

Start date: July 2016
Phase: N/A
Study type: Observational

The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.

NCT ID: NCT02613975 Completed - OSA Clinical Trials

A Cross Over Case Control Study of a Vibration Positional Device for Treatment of OSA

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

Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Positional OSA is present when the overall apnea hyponea index (AHI) is > 5/hr with a supine AHI being more than 2 times of AHI in other positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group 1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will be provided with a vibration device as treatment, which will be worn on the neck during sleep. This device senses the position of the patient during sleep. It will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of OSA. It will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. There will be a wash out period of 1 week in between the on and off period to remove any residual effect. Group 2 consists of patients with positional OSA who are using dental device but response or tolerated poorly. They will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. The device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. Informed consent will be signed. Each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.

NCT ID: NCT02459548 Completed - OSA Clinical Trials

Continuous Positive Airway Pressure (CPAP) for Primary Care

CPAP-SU-MAP
Start date: February 2014
Phase: N/A
Study type: Interventional

The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit. METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP. Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use >= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.

NCT ID: NCT02444806 Completed - COPD Clinical Trials

PSG Versus Oxim-capnography to Setup Home NIV

Start date: January 2015
Phase: Phase 2
Study type: Interventional

The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

NCT ID: NCT02438137 Completed - Clinical trials for Obstructive Sleep Apnea

Dimethyl Fumarate for Obstructive Sleep Apnea

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

The overall purpose of this study is to determine whether the oral medication dimethyl fumarate is an effective treatment for obstructive sleep apnea in patients who are unable, unwilling, or uneager to use positive airway pressure therapy.

NCT ID: NCT02387476 Completed - Clinical trials for Obstructive Sleep Apnea

Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea

Start date: October 2014
Phase: N/A
Study type: Interventional

This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.