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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03051815 Completed - Observation Clinical Trials

Influence of Craniofacial Restriction on Rebound of Obstructive Sleep Apnea Following Weight Gain

Start date: September 1, 2017
Phase:
Study type: Observational

Apart from obesity, craniofacial factors are well recognized in the pathogenesis of obstructive sleep apnea (OSA) and are likely to play an important role in influencing the response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway have shown that a shorter distance between maxillary projection from the cranial base, a smaller posterior airway space, less mandibular protrusion, a narrower space between the hard palate and cranial base, and a more caudally placed hyoid bone predispose to a higher apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as measured by lateral cephalometry was associated with a greater fall in AHI after weight loss. Another study using craniofacial computed tomography (CT) scans to evaluate the maxillomandibular bony volume found that craniofacial restriction influenced the relationship between weight loss and OSA improvement. Collectively, these studies suggest that the effect on AHI with weight loss is likely to be more pronounced in those with a smaller craniofacial skeleton. However, the effect of the craniofacial restriction on the degree of rebound in OSA following weight gain after the weight loss intervention is unknown. The study aims to investigate the change in weight and OSA severity following cessation of a lifestyle modification program (LMP) and examine the relationship between craniofacial restriction and the degree of OSA reoccurrence.

NCT ID: NCT03049982 Completed - Clinical trials for Obstructive Sleep Apnea

A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test

Start date: February 7, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

NCT ID: NCT03049306 Completed - Clinical trials for Obstructive Sleep Apnea

Propranolol for Sleep Apnea Therapy

ProSAT
Start date: February 15, 2017
Phase: Phase 2
Study type: Interventional

The primary objective in this study is to test whether propranolol lowers glucose and free fatty acid levels during sleep in obstructive sleep apnea (OSA), and preserves vascular function (EndoPAT) versus placebo. The secondary objective is to test whether propranolol influences sleep quality, architecture, and hemodynamics in OSA. OSA will be elicited by temporarily discontinuing CPAP therapy in patients with a history OSA accustomed to CPAP therapy (CPAP withdrawal).

NCT ID: NCT03048604 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

Start date: March 30, 2017
Phase: N/A
Study type: Interventional

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

NCT ID: NCT03047421 Completed - Clinical trials for Sleep Apnea, Obstructive

Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores

Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea). One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.

NCT ID: NCT03034447 Completed - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea in Asthmatic Children and Teenagers

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

Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more difficult to control. As girls usually have a more severe asthma than boys, the investigators believe that girls have a higher risk of sleep apnea. To test if asthmatic girls have more sleep apnea than boys, the investigators are going to ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators are going test the lung function and how many times they stop breathing during the sleep. The sleep test is going to be performed in children's home. In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when they have an asthma attack. We also are going to look if sleep apnea increases the number of hospitalizations and asthma attacks in the past 12 months.

NCT ID: NCT03032029 Completed - Clinical trials for Obstructive Sleep Apnea

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation

READ-ASV
Start date: September 5, 2017
Phase:
Study type: Observational [Patient Registry]

Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

NCT ID: NCT03020914 Completed - Clinical trials for Obstructive Sleep Apnea (OSA)

Effects of Audiovisual Distraction on Desaturation and Airway Intervention in OSA-patients

AVD
Start date: January 2017
Phase: N/A
Study type: Interventional

Patients will be randomly assigned to either one of two groups: 1. Standard of care sedation 2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library Monitoring and anesthesia regimen will be standardized

NCT ID: NCT03011762 Completed - Clinical trials for Sleep Apnea, Obstructive

Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy

Start date: November 2012
Phase: N/A
Study type: Interventional

Sleep apnea is a condition in which the throat air passage closes during sleep and repeatedly interrupts breathing. The standard treatment of sleep apnea is air pressure applied to the nose, so-called nasal CPAP, but it is not suitable for all patients. Another treatment is to use a dental appliance while asleep. In this treatment, an appliance covers the upper and lower teeth and acts to pull the jaw forward, which opens the throat passage. This allows the patient to breathe normally. Dental appliance treatment does not work effectively in all patients. In order to identify those in whom dental appliance therapy will be effective, the study sponsor has invented the remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized dental appliance which is used overnight in hospital sleep studies and works by pulling the jaw outward under the control of a technician. In order to eliminate the need for an overnight in hospital sleep study, the sponsor has invented a new device that allows for the identification of individuals who are suitable candidates for dental appliance therapy from the comfort of the home. Like with MATRx, participants will sleep with a motorized mandibular positioner in place. But, it is controlled by a computer, rather than a sleep technician, making it a computer controlled mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing using the CCMP will be evaluated through participation in this study. The sponsor has carried out two previous research trials leading to the development of the CCMP. The first established the predictive accuracy of the remotely controlled mandibular positioner at identifying candidates suitable for oral appliance therapy and their effective therapeutic setting. The second established the accuracy of the algorithms used by the CCMP to similarly identify successful candidates in a clinical setting. No significant problems were identified in conjunction with our previous research protocol, and no significant risks were identified. This third protocol is to establish the feasibility and accuracy of the CCMP when used in the home setting. The trial will utilize data collected over a series of nights to formulate a prediction of therapeutic outcome with an oral appliance. The prediction will be tested by comparing the degree of airway obstruction without treatment (from data collected prior to the study) to the degree of airway obstruction with oral appliance therapy. A custom fit oral appliance will be provided to participants as part of the trial. The purpose of the study is to test the predictive accuracy of the CCMP in identifying favorable candidates for oral appliance therapy and in determining an efficacious protrusive position. Another purpose is to evaluate the convenience and possibility of carrying out a multi-night CCMP study in the home. There are no known risks or side effects to the CCMP studies, to the home studies, or to the oral appliance therapy. It is possible that participants will have some discomfort during the nights of the CCMP studies but this will be transient and not cause any long term damage. Participants may experience soreness of the teeth or jaw joint during adjustment of the oral appliance by the dentist. There is no risk of jaw dislocation or problems with the temporomandibular joint (TMJ). Participants will have the benefit of receiving a dental appliance for treating their sleep apnea at no charge. This will be supplied to participants by a dentist who is an expert in this field. Participation in the study will also allow the further development and ultimately commercialization of the CCMP device which may help individuals who have sleep apnea. Dental appliance therapy is just one of two therapies for sleep apnea. If participants choose not to have the dental appliance therapy, they may wish to try nasal continuous positive airway pressure. Participants may withdraw at any time during the study without compromising their health care in any way. To withdraw, participants should simply notify one of the physicians or the research assistant. If the sponsor obtains new information that might affect an individual's willingness to participate in the study, they will be informed immediately.

NCT ID: NCT03011294 Completed - Clinical trials for Sleep Apnea Syndromes

Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea

SLEEP-PARTNERS
Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.