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Sleep Apnea, Obstructive clinical trials

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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.

NCT ID: NCT02383706 Completed - Pregnancy Clinical Trials

Obstructive Sleep Apnea in Pregnancy

OSAinPreg
Start date: February 2015
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.

NCT ID: NCT02364518 Completed - Clinical trials for Obstructive Sleep Apnea

TranQuillâ„¢ Sling Snoreplasty for Snoring and Mild Obstructive Sleep Apnea:

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

The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for the treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty (QSS) is a procedure where the suture will be inserted into the soft palate tissues for the treatment of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in the back of the roof of the mouth. The research results will be used to provide data on feasibility (strengths and weaknesses), safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of surgery that involved deep tissues in the body. The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie receive financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the only place that this study will be conducted. For this research study the investigators plan to enroll a total of up to 20 subjects at the Medical University of South Carolina.

NCT ID: NCT02364375 Completed - Clinical trials for Obstructive Sleep Apnea

Usability Evaluation of Menai CPAP Masks

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

The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.

NCT ID: NCT02357706 Completed - Clinical trials for Obstructive Sleep Apnea

Comparison of Auto-Adjusting Positive Airway Pressure Devices

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

Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.

NCT ID: NCT02349893 Completed - Apnea, Sleep Clinical Trials

Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study

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

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents. This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

NCT ID: NCT02348970 Completed - Clinical trials for Obstructive Sleep Apnea

Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices

IRIS
Start date: January 2015
Phase: N/A
Study type: Interventional

To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

NCT ID: NCT02348632 Completed - Clinical trials for Obstructive Sleep Apnea

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

NCT ID: NCT02348619 Completed - Clinical trials for Obstructive Sleep Apnea

"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

OSA
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

NCT ID: NCT02348606 Completed - Clinical trials for Obstructive Sleep Apnea

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

OSA
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.