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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03819361 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea

ELSA
Start date: February 1, 2019
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease. Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study. Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA. In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.

NCT ID: NCT03817762 Completed - Clinical trials for Obstructive Sleep Apnea Hypopnea Syndrome

Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

Start date: January 1, 2016
Phase:
Study type: Observational

The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

NCT ID: NCT03812692 Completed - Clinical trials for Obstructive Sleep Apnea

Validation of a Simplified MATRx Plus

Start date: February 6, 2019
Phase:
Study type: Observational

Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing. Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.

NCT ID: NCT03812653 Recruiting - Stroke Clinical Trials

Sleep for Stroke Management and Recovery Trial

Sleep SMART
Start date: May 9, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

NCT ID: NCT03811600 Completed - Cancer Clinical Trials

Exosomes Implication in PD1-PD-L1 Activation in OSAS

ExoSAS
Start date: March 3, 2019
Phase:
Study type: Observational

An increased occurrence of cancer associated mortality has been described in patients with Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an impaired cellular immune response that has been described in OSAS. Is has been suggested that OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation. This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to controls and will further investigate their impact on immune cells function and proliferation capacities.

NCT ID: NCT03810248 Completed - Clinical trials for Obstructive Sleep Apnea

Association Between Obstructive Sleep Apnea and Bruxism

Start date: July 17, 2019
Phase:
Study type: Observational

The objective of this retrospective observational study will be to investigate the between the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed through polysomnography (PSG).

NCT ID: NCT03804827 Completed - Clinical trials for Obstructive Sleep Apnea

Sleep Disordered Breathing in Acute Congestive Heart Failure

Start date: January 14, 2019
Phase:
Study type: Observational

The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. A secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.

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: NCT03796026 Completed - Clinical trials for Sleep Apnea, Obstructive

A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea

Start date: January 4, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.

NCT ID: NCT03792880 Completed - Clinical trials for Obstructive Sleep Apnea

Global Self-management Telematic Support for Patients With Obstructive Sleep Apnea.

TELESAS
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

This clinical trial compares the usual follow-up to a program of telematic control and self-management in a group of patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS), few symptoms and treated with continuous positive airway pressure (CPAP). The objective of the intervention is to achieve a CPAP compliance of ≥4 hours per day in at least 90% of the subjects.