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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT04071314 Recruiting - Healthy Clinical Trials

Evaluating the Alimentary and Respiratory Tracts in Health and Disease (EARTH) Research Program.

EARTH
Start date: April 18, 2018
Phase:
Study type: Observational

The investigators have established the "Evaluating the Alimentary and Respiratory Tracts in Health and disease" (EARTH) research program. It provides a structured approach to analysing gastrointestinal and respiratory microbiomes, along with diet and symptomatology, in children with a gastrointestinal and/or respiratory condition with recognised long-term morbidity (e.g. cystic fibrosis, obstructive sleep apnoea, or Hirschsprung's disease). The EARTH program consists of a series of prospective, longitudinal, controlled, observational studies, with each individual study comparing children with a chronic gastrointestinal and/or respiratory condition to healthy controls (HC). It will be conducted in an Australian tertiary paediatric hospital (although the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared to age and gender matched HC across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) a stool sample, (ii) an oropharyngeal swab or sputum sample, (iii) a semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life, and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro- and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will also be compared between children with a condition and HC. The investigators hypothesise that: (i) Children with chronic gastrointestinal and/or respiratory conditions will have altered intestinal and respiratory microbiomes compared to healthy children, and (ii) Diet plays a key role in influencing the intestinal and respiratory microbiomes and this may impact on clinical outcomes, biomarkers of disease, and health-related quality of life.

NCT ID: NCT04063917 Completed - Clinical trials for Obstructive Sleep Apnea

Safety, and Tolerability of the ZENS Device (PLUTO)

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

The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).

NCT ID: NCT04063436 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Start date: September 23, 2019
Phase: N/A
Study type: Interventional

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

NCT ID: NCT04061226 Completed - Sleep Disorder Clinical Trials

Relationship Between Normal-weight Central Obesity and Obstructive Sleep Apnea

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

Comparison of the prevalence of obstructive sleep apnea (OSA), measured by polysomnography in normal weight patients with central obesity by body mass index (BMI) and waist hip ratio (WHR), with normal weight patients without central obesity by BMI and WHR. Evaluation of arterial stiffness and vascular age in normal weight patients with central obesity and in normal weight patients without central obesity. Determination of the exercise response characteristics in OSA patients.

NCT ID: NCT04054180 Terminated - Clinical trials for Obstructive Sleep Apnea Syndrome

Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): (SLEEPCONNECT)

SLEEPCONNECT
Start date: June 7, 2021
Phase: N/A
Study type: Interventional

Continuous positive airway pressure (CPAP) is the first line therapy for Obstructive Sleep Apnea Syndrome (OSAS) but has limited impact for reducing cardio-metabolic risk. Combined treatment strategies including physical activity and weight loss management have emerged in association with CPAP. Patient's engagement might be supported by connected devices and smartphone applications measuring physical activity, blood pressure, weight and sleep duration. Data fusion of these parameters with CPAP-remote telemonitoring will allow personalized coaching and integrated care of OSAS with cardio-metabolic co-morbidities.

NCT ID: NCT04053153 Withdrawn - Sleep Apnea Clinical Trials

Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.

NCT ID: NCT04050514 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Side Effects of Mandibular Advancement Devices

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

Sleep-related breathing disorders (SBAS) are one of the most common causes of non-restorative sleep. Sleep therapy options include positive pressure ventilation with continuous positive airway pressure (CPAP) masks, mandibular advancement of the mandible with mandibular advancement devices (MAD), back restraining, weight reduction, ear, nose and throat surgical procedures, bimaxillary or mandibular remodeling osteotomies, and neurostimulation procedures N. hypoglossal. In mild to moderate obstructive sleep apnea syndrome (OSAS), MAD, back suppression and weight reduction are potential treatment options. This study aims to identify possible side effects in the temporomandibular system that occur during nocturnal support of a mandibular arch over two years. Two different MADs are compared in terms of construction, height (bite elevation) and protrusion mechanics: the H-MAD with an hinge system according to Herbst and the SomnoDent Fusion ™ MAD (called F-MAD) with sliding side wings. In addition, it is to be evaluated whether hinge system according to Herbst as a protrusion-controlling element and the reduction of the splint body for a reduced bite elevation leads to a significant reduction of side effects compared to the F-MAD.

NCT ID: NCT04031040 Recruiting - Clinical trials for Obstructive Sleep Apnea

A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

EliSA
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

NCT ID: NCT04029311 Completed - Clinical trials for Treatment for Obstructive Sleep Apnea

Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

Start date: June 8, 2017
Phase: N/A
Study type: Interventional

To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of: 1. Apnea Hypopnea Index (AHI) reduction 2. Amount of side effects 3. Amount of Leaks 4. Hours of use (compliance) 5. CPAP pressure 2. There is a difference between connected and disconnected for the following symptoms: 1. Epworth sleepiness Scale (ESS) 2. Functional Outcomes of Sleep Questionnaire (FOSQ) 3. Side effects Study Design - randomized prospective parallel

NCT ID: NCT04028011 Recruiting - Clinical trials for Obstructive Sleep Apnea

Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea

Start date: September 30, 2019
Phase:
Study type: Observational

This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.