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Obstructive Sleep Apnea clinical trials

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NCT ID: NCT03362671 Terminated - Clinical trials for Obstructive Sleep Apnea

Implant Supported Oral Appliance Treatment of OSA

BIMA
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults. The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement. The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm. The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices. Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.

NCT ID: NCT03247907 Terminated - Clinical trials for Obstructive Sleep Apnea

Humidification Needs

Start date: October 9, 2017
Phase: N/A
Study type: Interventional

A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.

NCT ID: NCT03109418 Terminated - Clinical trials for Obstructive Sleep Apnea

Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea

Start date: June 2, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.

NCT ID: NCT03061019 Terminated - Clinical trials for Obstructive Sleep Apnea

Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea

PERSIST-B
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).

NCT ID: NCT03051165 Terminated - Clinical trials for Obstructive Sleep Apnea

Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea

Start date: November 21, 2016
Phase: N/A
Study type: Interventional

This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study site will be told about the study at their 2-week post-operative appointment. Those who decide to participate will have blood drawn and vascular function measurements taken before HGNS activation, during treatment, and after a temporary treatment withdrawal period. Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.

NCT ID: NCT03025464 Terminated - Clinical trials for Obstructive Sleep Apnea

Validation of Sleep Apnea Screening Device Phase II

Start date: November 14, 2017
Phase: Phase 2
Study type: Interventional

Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Over the past year, this investigative team has engineered a small screening device (Zerify®) for OSA and obtained preliminary evidence of its efficacy in a clinical population under a NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data, transfer these data to a computer, and detect non-clinical simulated apnea events with a specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary psychometric performance data of the screening device in a clinical sample of 52 patients (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard polysomnography. Phase II proposal aims to optimize the engineered hardware and associated OSA algorithms, create a patient companion app and wireless healthcare provider dashboard, and compare the efficacy of this screening device to the most commonly utilized sleep apnea screener, the home sleep apnea test (HSAT).

NCT ID: NCT02971436 Terminated - Clinical trials for Obstructive Sleep Apnea

Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

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

This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

NCT ID: NCT02930460 Terminated - Clinical trials for Obstructive Sleep Apnea

Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.

PoP IN VAuto
Start date: November 2016
Phase:
Study type: Observational

Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

NCT ID: NCT02885571 Terminated - Clinical trials for Obstructive Sleep Apnea

Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients

Start date: April 21, 2016
Phase: N/A
Study type: Interventional

This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.

NCT ID: NCT02763813 Terminated - Clinical trials for Obstructive Sleep Apnea

Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome

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

Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.