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NCT ID: NCT03796078 Recruiting - OSA Clinical Trials

Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period: - Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1). - Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery. - Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist) - Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12). - Record of body mass index (BMI) (cm/Kg2) Main Objective: • Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives: • Interrelate the degree of dentofacial deformity with the IAH. - Study the potential correlation between the volume of the VAS and the IAH. - Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS). - Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA. - To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA. - Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA. - Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term. - Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis - H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term. - H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.

NCT ID: NCT03721445 Recruiting - OSA Clinical Trials

Could HRV be a Valuable Predictor for CPAP Adherence?

Start date: October 2, 2018
Phase:
Study type: Observational [Patient Registry]

This study aim to evaluate if the improvement of heart rate variability for the continuous positive airway pressure titration night can predict the short and long term continuous positive airway pressure adherence for patients with moderate to severe OSA.

NCT ID: NCT03431103 Recruiting - COPD Clinical Trials

The Effect of Exercise on Systemic Inflammation in Veterans With COPD and OSA

Start date: December 5, 2016
Phase: N/A
Study type: Interventional

The overlap syndrome (OS), i.e. the association of both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) in a single Veteran, is prevalent and associated with increased cardiovascular disease (CVD) morbidity. Home-based exercise interventions that translate to a lifestyle with increased physical activity (PA) are an ideal strategy as 150 minutes of leisure time PA a week is associated with a significant reduction in risk of CVD related events and death. This novel research study will help develop a home exercise intervention that is largely accepted by OS Veterans, as a first step toward implementing PA into the routine medical care of the large Veteran population with COPD and OSA. This data will be used for larger studies on CVD risk and its modification with exercise in OS, a research area that is urgently needed given its high impact on Veterans' morbidity, mortality and health-care associated costs.

NCT ID: NCT03295019 Recruiting - Sleep Apnea Clinical Trials

"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.

NCT ID: NCT02749565 Recruiting - Asthma Clinical Trials

The Role of Endothelium A and EGFR Receptor in Fibrocytes From Asthma With Obstructive Sleep Apnea

Start date: January 2015
Phase:
Study type: Observational

The investigators will compare the circulating fibrocyte proportion in asthmatic patients with obstructive sleep apnea (OSA) and not with OSA In addition, the investigators will compare the expression of epidermal growth factor receptor (EGFR), endothelin A receptor (ETAR) and connective tissue growth factor (CTGF) The association of those factors and annual decline of forced expiratory volume in 1 second (FEV1) will be performed

NCT ID: NCT01828216 Recruiting - OSA Clinical Trials

Ambulatory Versus Conventional Approach Diagnosing OSA

Start date: January 2013
Phase: N/A
Study type: Interventional

Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing OSA, identifying patients who benefit from CPAP, and reducing the need for PSG. This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the conventional approach in managing OSA in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.