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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT02695667 Terminated - Clinical trials for Obstructive Sleep Apnea

Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS)

EatonOSAS
Start date: February 2016
Phase:
Study type: Observational [Patient Registry]

Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive

NCT ID: NCT02693977 Completed - Clinical trials for Obstructive Sleep Apnea

Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy

Start date: February 1, 2015
Phase:
Study type: Observational

Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in breathing during sleep. It affects at least 1-3% of the general pediatric population with greater prevalence among certain high risk groups such as children with obesity, Down syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown that, even after having adenotonsillectomy (AT), approximately 30% of children continue to struggle with OSA. They further found that older children (age > 7 yrs), obesity, and high pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these known risk factors, the ability to predict each individual patient's risk of residual OSA after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an important step towards more effective post-surgery OSA management. The purpose of this study is to determine whether sleep endoscopy can predict whether their AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple areas of obstruction in addition to large tonsils will be more likely to have residual OSA after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves passing a flexible endoscope through the subject's nose into the back of the throat to look for sources of obstruction while breathing spontaneously. This will be a prospective cohort study examining subjects between the ages of 2 and 18 who are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for residual OSA after surgery. High risk will be defined based on the following criteria: obesity, Down syndrome, African American race, severe baseline OSA, and age > 7 yrs. Eligible subjects will be recruited from the pediatric otolaryngology clinic at the time of initial evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the time of AT. All patients will be asked to complete a preoperative sleep study to confirm the diagnosis of OSA and a postoperative sleep study to determine the impact of AT and the presence of residual OSA. Secondary outcome measures will include several questionnaires assessing generic and OSA-specific quality of life as well as subjective measures of cognitive/executive functioning and daytime sleepiness.

NCT ID: NCT02687997 Completed - Lung Cancer Clinical Trials

Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort

SAILS
Start date: February 2016
Phase: N/A
Study type: Interventional

Prospective study of sleep disordered breathing in a lung cancer screening cohort.

NCT ID: NCT02687477 Terminated - Clinical trials for Obstructive Sleep Apnea Syndrome

PADN to Treat Severe Obstructive Sleep Apnea

PADN-OSA
Start date: February 2016
Phase: N/A
Study type: Interventional

This project is focused on the treatment of severe obstructive sleep apnea with pulmonary artery denervation (PADN). Although it has now been proved that continuous positive airway pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand, there is evidence that 25 to 50% of patients can not tolerate CPAP. The investigators previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an important role in the occurrence and development of OSA and cause cardiovascular events. It is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and feasibility of PADN in the treatment of severe OSA.

NCT ID: NCT02685579 Withdrawn - Sleep Apnea Clinical Trials

The Effect of Obstructive Sleep Apnea Treatment on Dizziness, Vertigo

OSATDV
Start date: June 2016
Phase: N/A
Study type: Observational

Obstructive Sleep Apnea may cause dizziness or vertigo through hypoxia of the vestibular nuclei in the brain. Treating sleep apnea may improve dizziness or vertigo.

NCT ID: NCT02685202 Terminated - Myalgia Clinical Trials

Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the course of temporomandibular disorder (TMD) pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated with mandibular advancement splint (MAS) therapy. Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA (apnea-hypopnea index ≥5 and <30). This is an interventional study in which 12 patients receive MAS therapy for comorbid TMD/OSA for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy, the the effect on MAS therapy on TMD pain in people with OSA is unknown. There is no comparison group. Care is being provided under the direction of a sleep physician by a dentist who specializes in dental sleep medicine. The investigators expect that as MAS therapy reduces the severity of OSA, painful TMD symptoms will also reduce.

NCT ID: NCT02683616 Completed - Clinical trials for Obstructive Sleep Apnea

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

FAMOSA
Start date: April 1, 2015
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the development of glucose intolerance and T2DM. The project is targeting the gap in providing effective treatment of metabolic impairments associated with OSA, particularly T2DM. In contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP treatment, as investigators suggested recently. Clearly, the search for additional treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM development. The aim of the study is to target adipose tissue and muscle dysfunction leading to elevated FFA and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of FFA oxidation.

NCT ID: NCT02677168 Completed - Clinical trials for Sleep Apnea, Obstructive

cNEP for the Treatment of Obstructive Sleep Apnea

cNEP
Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea

NCT ID: NCT02675816 Terminated - Clinical trials for Obstructive Sleep Apnea

Inspire® Upper Airway Stimulation System

RCT
Start date: August 2015
Phase: Phase 4
Study type: Interventional

The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.

NCT ID: NCT02666781 Completed - Clinical trials for Obstructive Sleep Apnea

Postoperative Rostral Fluid Shift and Obstructive Sleep Apnea

Start date: April 22, 2016
Phase:
Study type: Observational

Patients with obstructive sleep apnea (OSA) are more likely to experience postoperative complications and impact significantly on healthcare resources. In the surgical population, the type and volume of IV fluid administration may contribute to the worsening of postoperative sleep apnea but the pathophysiological mechanisms have not been elucidated. Recent research from general population suggests that intravenous (IV) fluid administration worsens the severity of OSA by shifting of fluid from the legs to the neck thus increasing neck size and causing airway collapse. In this novel study, our objective is to examine the contribution of IV fluid administration and rostral fluid shift from the legs to the neck thereby leading to worsening of sleep apnea following surgery. In this prospective observational cohort study, 25 consecutive adult patients, requiring at least 2 days hospital stay, will be recruited. Following informed consent, patients will undergo portable home sleep study to determine the preoperative severity of sleep-disordered breathing. On the day of surgery, leg, neck and total body fluid volumes will be recorded, and patients will undergo general anesthetic. The results of this study will be used to design future clinical trials evaluating methods to decrease postoperative OSA worsening, as well as decreasing OSA-related postoperative complications.