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Apnea clinical trials

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NCT ID: NCT03246477 Completed - Clinical trials for Obstructive Sleep Apnea

Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients

MIMOSA
Start date: September 2016
Phase:
Study type: Observational

Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates, improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse has been described in the target population, especially when associated with significant weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The surgeons of the Division of Maxillofacial Surgery already started to perform this type of surgery in 1995. Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery) biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the stability of hard and soft tissues and polysomnographic results. Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography and quality of life questionnaires will be retrieved from all patients that were surgically treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999. Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However, long-term data are lacking. This retrospective study might provide us with more information about the incidence of clinical relapse fifteen to twenty years after surgery.

NCT ID: NCT03242148 Completed - Clinical trials for Obstructive Sleep Apnea

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

Start date: September 16, 2017
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 of the F&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

NCT ID: NCT03238937 Withdrawn - Heart Failure Clinical Trials

Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

STIMULATE-CSA
Start date: October 5, 2017
Phase: N/A
Study type: Interventional

The study objectives are to demonstrate the ease and safety of bilateral cervically implanted phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a form of hypoventilation syndrome, for which this device is FDA approved. We will also determine if the patient's quality and duration of life is improved by using the PNS to treat CSA in heart failure patients.

NCT ID: NCT03232658 Recruiting - Clinical trials for Obstructive Sleep Apnea

The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea

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

Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently, clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing cessation event frequency during the night. Longer obstruction events and deeper desaturations have been suggested to be more harmful than shorter and shallower events and these individual characteristics are completely neglected by conventional and currently used AHI. The investigators have previously introduced novel diagnostic parameters incorporating the number, duration and morphology of individual obstruction events and shown that they improve the severity estimation of OSA compared to traditional measures. Even though, the novel diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be refined to further increase the accuracy of the OSA severity estimation. It has been shown that age, body mass index (BMI) and sleeping position are strongly related to the severity OSA. However, it is not thoroughly studied whether the severity of individual obstruction events progress over time (the aging process) and which factors affect to this progression. It is known that OSA patients with similar AHI values, durations of individual breathing cessation events can differ significantly. Longer and deeper events are connected to increased mortality rate in patients with moderate or severe OSA and thus, could be considered to be more detrimental than shorter and shallower ones. However, it has not been thoroughly investigated whether in severe OSA patients with identical AHI values, sleep efficiency or hypertension is related to the severity of individual breathing cessation events. The investigators planned to explore, whether the individual breathing cessation event severity progress over time and how different confounding factors affect this progression. Furthermore, the correlation of EDS with the individual breathing cessation event severity, sleep structure, and frequency and occurrence of cortical arousals will be investigated. Also, the investigators will explore whether the percentage time of disturbed breathing from total sleep time is related to sleep efficiency or hypertension in severe OSA patients having similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture during sleep is the treatment of choice for Positional Patients (PP) having most of their breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are more severe while sleeping supine, this time the investigators will assess the therapeutic value of PT for severe Non Positional patients (NPP).

NCT ID: NCT03230877 Completed - Clinical trials for Obstructive Sleep Apnea

The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Start date: September 2, 2017
Phase:
Study type: Interventional

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

NCT ID: NCT03230110 Completed - Hypertension Clinical Trials

OSA in Pregnant Women With Chronic HTN

OSA-CHTN
Start date: June 16, 2017
Phase:
Study type: Observational

The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device

NCT ID: NCT03226652 Completed - Heart Failure Clinical Trials

Heart Function in Patients Assessed for Sleep Apnoea

Start date: July 24, 2017
Phase:
Study type: Observational

This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).

NCT ID: NCT03224286 Completed - Apnea Clinical Trials

Pressure Sensitive Mats for Patient Monitoring in the NICU

Start date: January 22, 2018
Phase:
Study type: Observational

This is a pilot study that provides the investigators with an opportunity to assess the application of PSM technology for patient monitoring in the NICU. This is a prospective, observational, cohort study.The investigators expect the duration of infant participation in this study to be 6 hours per single recording session with no follow-up required.

NCT ID: NCT03223467 Completed - Obesity Clinical Trials

Obstructive Sleep Apnea, Predictors and Bariatric Surgery

Start date: January 4, 2012
Phase: N/A
Study type: Interventional

Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al. 2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.

NCT ID: NCT03221205 Completed - Obesity Clinical Trials

Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients

Start date: October 15, 2014
Phase: N/A
Study type: Interventional

This study evaluates the effect of the use of nasal CPAP in the cardiac function, measured by strain and TEI index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and obesity. In order to do so, 76 patients will be studied, half will use sham CPAP and half will use therapeutic CPAP for three months, with echocardiogram, laboratory studies, ambulatory monitoring of arterial tension and sleep study before and after CPAP use.