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Apnea clinical trials

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NCT ID: NCT04801771 Recruiting - Clinical trials for Obstructive Sleep Apnea

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Start date: June 24, 2021
Phase: Phase 3
Study type: Interventional

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

NCT ID: NCT04800341 Recruiting - Sleep Apnea Clinical Trials

Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

ESADAfollow-up
Start date: May 12, 2021
Phase:
Study type: Observational

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean. An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

NCT ID: NCT04795817 Completed - Clinical trials for Obstructive Sleep Apnea

Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System

Start date: January 27, 2021
Phase:
Study type: Observational

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

NCT ID: NCT04793334 Enrolling by invitation - Obesity Clinical Trials

Underlying Mechanisms of Obesity-induced Obstructive Sleep Apnea

Slim-OSA
Start date: March 20, 2021
Phase:
Study type: Observational

Obesity is a common risk factor for the development of obstructive sleep apnea. However, not all subjects with obesity develop obstructive sleep apnea. This study will attempt to determine the mechanistic drivers between obesity and obstructive sleep apnea.

NCT ID: NCT04793178 Completed - Hypoxemia Clinical Trials

The Effectivity of End-tidal CO2 and Oxygen Reserve Index (ORI) Monitoring in Sedation

Start date: December 25, 2015
Phase: N/A
Study type: Interventional

Endoscopic procedures are commonly performed using sedation. As drug-induced respiratory depression is a major cause of sedation-related morbidity, pulse oximetry has been established as standart practice . However SpO2 does not completely reflect ventilation. Capnography is an additional monitoring parameter which demonstrates respiration activity breath by breath. Unfortunately, in the state of moderate or deep sedation during diagnostic or therapeutic procedures (e.g.ERCP or colonoscopies), regular breathing is often disturbed by moving, squeezing, coughing or changes between nose and mouth ventilation causing leakage and therefore artifacts or misinterpretation of data acquired with ETCO2. These problems often restrict the use of side-stream capnography in clinical practice, although the American Society of Anesthesiologists have suggested in their guidelines that extended monitoring with capnography 'should be considered'in deep sedation. The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg). The ORI is an "index" with a unit-less scale between 0.00 and 1.00 that can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen status. When utilized in conjunction with SpO2 monitoring the ORI may extend the visibility of a patient's oxygen status into ranges previously unmonitored in this fashion. The ORI may make pre-oxygenation visible, may provide early warning when oxygenation deteriorates, and may facilitate a more precise setting of the required FiO2 level. In this study we aimed to show effectivity of capnography and ORİ monitoring to avoid respiratory events and hypoxia in sedated endoscopic patients. In this study we targeted totally 300 sedated endoscopy patients. Patients will randomize to two groups. In Group I anaesthesiologis will be able to use all the monitoring, where as in Group II will be blinded for ORİ. We will apply pre-oxygenation to obtain long safe apnea time. Approximately 5 min pre-oxygenation (5L/min via nasal cannula) will be used to reach steady state in oxygen reserve. We defined hypoxemia ; SpO2<95% and severe hypoxemia SpO2≤90%, hypoventilation; rise10 mmHg in ETCO2 compare to baseline, ETCO2≤30 mmHg and flat capnography.

NCT ID: NCT04789174 Completed - Clinical trials for Obstructive Sleep Apnea

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

SHARP
Start date: May 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired cognitive function.

NCT ID: NCT04778748 Completed - Clinical trials for Sleep Apnea, Obstructive

Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea

Start date: April 22, 2021
Phase:
Study type: Observational

A device has been developed which is placed under the mattress, thereby escaping contact with patient, which enables monitoring of sleep activity and has been shown in some studies to provide an estimate of the frequency of sleep disordered breathing. If the estimates of sleep disordered breathing from this new device are medically equivalent to current excepted home sleep apnea test devices within clinically important ranges of sleep disordered breathing, it may have several benefits. This study is designed to help answer several important clinical questions, namely, is the new device clinically equivalent to an established HSAT device for patients who have at least moderately severe OSA, and what is the effect of multiple nights on classification of severity and presence of OSA.

NCT ID: NCT04774692 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Trained Patients as Research Partners in Sleep Apnea

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

The primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP

NCT ID: NCT04768543 Completed - Clinical trials for Obstructive Sleep Apnea

Stimulation Therapy for Apnea: Reporting Thoughts

START
Start date: March 2, 2020
Phase:
Study type: Observational

Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.

NCT ID: NCT04767867 Completed - Anesthesia Clinical Trials

Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen

PREOX
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Pre-oxygenation increases oxygen reserves in the body to reduce the likelihood of oxygen desaturation on induction of general anaesthesia. Pre-oxygenation with facemask is the commonest method method of pre-oxygenation. High-flow nasal oxygen is a newer alternative. This study randomises participants to receive pre-oxygenation by one of three methods: facemask, high-flow nasal oxygen, high-flow nasal oxygen plus mouthpiece.