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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT02297789 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

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

Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

NCT ID: NCT02296840 Terminated - Clinical trials for Obstructive Sleep Apnea

Post-operative Pain Control After Pediatric Adenotonsillectomy

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or re-admission to the hospital. Post-operative analgesia is most commonly managed with narcotic-containing pain medication. In recent years however, there is evidence that some patients may manifest increased sensitivity to narcotics, resulting in life-threatening respiratory compromise. Though there is a theoretical risk that nonsteroidal anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation, evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains inconclusive for these generally well-tolerated medications. The goal of this study is to determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in the management of post-operative pain following pediatric adenotonsillectomy, versus more commonly used narcotic pain medication. The study design will be an initial retrospective study to collect pilot data on the incidence of postoperative hemorrhage and indicators of adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This will be followed by a prospective, randomized, single-blind controlled study in which orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone (control intervention) in the postoperative period following adenotonsillectomy.

NCT ID: NCT02295306 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea (OSA)

Overnight Polysomnography and Respiratory Volume Monitor

Start date: June 2013
Phase:
Study type: Observational

Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting 8-12% of the general population and often more than 70% of the bariatric surgical population. OSA is characterized by the repetitive collapse of the upper airway, causing a reduction or cessation in airflow and decreases in oxygen saturation. These events are resolved by arousals from sleep, reducing sleep quality and leading to excessive daytime sleepiness. An in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of OSA. Previous studies have established obstructive sleep apnea (OSA) as a potential independent risk factor for postoperative complications, adverse surgical outcomes, and longer hospital stays. Patients with OSA have an increase in postoperative complications, the most frequent being oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk for OSA. It has been suggested that OSA events may be even more frequent post operatively because of the residual effects of anesthesia and the use of potent pain medications such as opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental O2 may mask any desaturations and there is no convenient technology to noninvasively monitor ventilation to detect apnea and hypopnea in post-surgical patients. New advances in technology and digital signal processing have led to the development of an impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.

NCT ID: NCT02295202 Completed - Metabolic Syndrome Clinical Trials

Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

TREATOSA-MS
Start date: March 2015
Phase: Phase 4
Study type: Interventional

Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.

NCT ID: NCT02293746 Completed - Clinical trials for Obstructive Sleep Apnea

Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

Start date: June 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

NCT ID: NCT02293421 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic

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

Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA is associated with a large number of co-morbidities, and thus, it is of great importance to identify the patients and start treatment in order to reduce the risks for complications. Current screening tools are quite unspecific and the golden standard methodology for diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening. In perioperative medicine the STOP BANG screening questionnaire is currently the recomended screening tool, however this questionnaire has only been evaluated in a sleep clinic in a very limited numbers of patients.

NCT ID: NCT02290236 Enrolling by invitation - Clinical trials for Sleep Apnea, Obstructive

Monitored Saturation Post-ICU

Start date: September 2014
Phase: N/A
Study type: Observational

The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.

NCT ID: NCT02289625 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Effects of Exercise Training on Cognitive Performance and Sympathetic Activity in Obstructive Sleep Apnea

Start date: October 2010
Phase: N/A
Study type: Interventional

Abstract Obstructive sleep apnea syndrome (OSA) is characterized by complete or partial collapse of a narrowed pharynx and it's associated with reduction in cerebral blood flow, cardiovascular disease, and neuropsychological deficits and reduces survival. In patients with AOS structural, metabolic and hypoperfusion cerebral were associated not only with physiological functions but also with attention and executive function. There is a higher association between apnea hypopnea index and Mini-Mental State Examination in individuals with the exon 4 of APO E gene, indicating that exon 4 of APO E gene confers an increased risk for cognitive decline in individuals with sleep apnea. The analysis of presence and consequences of OSA in cerebral structure, inflammation and neurovascular control can permit a better investigation of abnormalities in these individuals and implement interventions to reduce the risk of development of cognitive and cardiovascular impairment. The non-pharmacological intervention through exercise training can represent an important strategy for improvement in cerebral alterations, cognition and reduction in sleep apnea index. The purpose of present study is investigate the volume and metabolism cerebral, neurovascular control, cognition and exon 4 of APO E gene and their

NCT ID: NCT02279901 Completed - Clinical trials for Obstructive Sleep Apnea

Impact of Automated Education and Follow-up Mechanisms on Patient Engagement

EmmiUSleep
Start date: November 2014
Phase: N/A
Study type: Interventional

The primary and well-known challenge with continuous positive airway pressure (CPAP) is the incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with obstructive sleep apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and self-directed methods of educating and follow-up is needed. The investigators plan to investigate the impact of adjunct Web education and automated follow-up on CPAP use and other measurements of patient engagement. The specific aims of this pilot study are as follows: 1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to usual standard of care. 2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of healthcare utilization at 3 months after initiation of therapy in comparison to usual standard of care.

NCT ID: NCT02278094 Completed - Clinical trials for Obstructive Sleep Apnea

The Influences of Intervention With Home-based Recovery Activity in Obstructive Sleep Apnea Syndrome

OSAS
Start date: September 2014
Phase: N/A
Study type: Interventional

Background: OSAS is a type of sleep disorder characterized by intermittent, partial or complete upper airway (UA) collapse, seriously impacting sleep apnea and respiratory insufficiency. The major upper airway dilator muscle (genioglossus) is more active during periods of stable breathing compared with periods of cyclical breathing when obstructive apneas occurred. UA muscle strength is linearly related to the inspiratory pump muscle strength. The ratios of UA muscle strength (tongue protrusion, TP) and inspiratory pump muscle strength (PImax) were not different between individuals with and without OSAS. However, a highly wakeful ratio of TP force to PImax appears to be associated with a reduced propensity to moderate-to-severe OSAS. Up to 95% of OSAS cases are treated with continuous positive airway pressure (CPAP), which is the most effective, commonly used, and low-risk treatment method. However, patients using CPAP therapy could face ongoing difficulties. Aims: To evaluate the effects of home-based exercise for patients with moderate to severe OSAS. This study was a randomized clinical trial conducted at three different intervention protocols as experimental groups. We will use cluster random sampling assign to each group. CPAP treatment group will be the control group. Methods: Subject above 20 years old will be diagnosed to moderate and severe OSAS. Subjects will be assign to walking exercise (WE), Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups. We will compare the Polysomnography (PSG) data, Epworth Sleepiness scale (ESS), World Health Organization Quality of Life( WHOQOL) questionnaire is a shorter version of the original instrument (WHOQOL-BREF), 6-minute walking test (6MWD), rate of perceived exertion scale (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strength, anthropometric data and daily note at baseline, 3 months (end-of-intervention) and 6 months (post intervention follow-up) in patients with moderate to severe OSAS. They will undergo three months of the home-based exercises. Patients will be followed up with weekly telephone calls and be interviewed monthly. Expected results: By using the WE, TIMT and TMT therapies, the airway collapse during sleep will be prevented when the whole body muscle strength, inspiratory pump muscle strength and tongue muscle strength are enhanced.