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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT04262557 Completed - Clinical trials for Sleep Apnea Syndrome, Obstructive

Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

SENSAPNEA
Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis. The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

NCT ID: NCT04262453 Completed - Clinical trials for Upper Aerodigestive Tract Neoplasms

Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

SAOS-K
Start date: January 21, 2019
Phase:
Study type: Observational

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract. The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)

NCT ID: NCT04251975 Completed - Clinical trials for Obstructive Sleep Apnea

Masked Hypertensive Patients With Obstructive Sleep Apnea

Masked-OSA
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The general objective is to evaluate the effect of continuous positive airway pressure (CPAP) treatment in patients with masked hypertension. The secondary objectives are: i) To evaluate the prevalence of different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) (dipper / non-dipper); ii) To assess in these patients the relationship between compliance with CPAP treatment and the response to nocturnal BP; iii) To identify variables of the ABPM, and biomarkers that are related to the unfavourable pattern of nocturnal BP response in these patients treated with CPAP; iv) To evaluate the change in the profile of biomarkers with the treatment. Methodology: Open, parallel, prospective, randomized and controlled study in which an ABPM will be performed in individuals with masked hypertension referred to the sleep unit and diagnosed of OSA (AHI≥ 30) without sleepiness (Epworth≤18). A total of 64 subjects with OSA and masked hypertension will be recruited. It will be collected blood for the determination of biomarkers. Subsequently, they will be randomized to receive treatment with CPAP (32) or conservative treatment (32). After 3 months of initiation, ABPM and biological determinations will be repeated.

NCT ID: NCT04246320 Completed - Clinical trials for Obstructive Sleep Apnea

Taking Brain Monitoring to the Next Level

HDBRAIN
Start date: January 30, 2020
Phase: N/A
Study type: Interventional

This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).

NCT ID: NCT04236440 Completed - Clinical trials for Sleep Apnea, Obstructive

Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration

KOALA
Start date: February 4, 2020
Phase: Phase 2
Study type: Interventional

The researchers in this study want to learn how drug BAY2586116 works in patients with obstructive sleep apnea (OSA). OSA is a sleep disorder marked by breathing pauses during sleep due to repetitive obstructions of the upper airway. BAY2586116 is a new drug under development for the treatment of OSA. It blocks protein channels expressed on the surface of the upper airways in small mechanoreceptors (a type of molecule that sense and pass stimulus outside a cell on to the inside of the cell through mechanical gate on the surface of the cell). Thus, the negative pressure reflex alerting the brain of inspiration is triggered more easily leading to a stronger activation of throat muscles. This prevents narrowing or collapse of the upper airways during sleep which is one of the pathological key factors in OSA. Researchers will study the effects of different routes of administration (drops into the nose, spray into the nose or throat or spray into the throat by endoscopy). Endoscopy allows the doctor to look at areas in the throat that cannot be seen with a mirror: a thin tube-like instrument is inserted through the nose to check and give the medication. Different doses of the test drug will be given. They also want to find out if participants experience any medical problems during the study. Patients participating in this study will undergo three study parts. After completing Part A and Part B, participants will be asked to join Part C. In Part A, participants will receive both the test drug and placebo (a placebo looks like the test drug but does not have any medicine in it); in Part B, participants will receive the test drug twice via different routes of administration (drops in nose and spray in nose or throat) and in Part C, the participants would receive the test drug once via spray in throat by endoscopy. The sleep of the participants will be monitored by medical equipment. Participants will be asked to visit the clinic 7 times in 14 weeks in total.

NCT ID: NCT04235023 Completed - Inflammation Clinical Trials

PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

MacroSAS
Start date: February 4, 2020
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization. Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis. As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.

NCT ID: NCT04234074 Completed - Clinical trials for Central And Obstructive Apnoeas In Infants

Improved Discrimination Of Central And Obstructive Apnoeas In Infants

Start date: February 28, 2014
Phase: N/A
Study type: Interventional

Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in their breathing] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases. In order to fully assess an infant, a full-scale overnight polysomnography study would be required. Unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). This is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. This new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry. This is likely to provide a substantial and significant improvement on our current practice. The benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.

NCT ID: NCT04232410 Completed - Clinical trials for Obstructive Sleep Apnea

Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)

Pcrit-DISE
Start date: January 15, 2020
Phase:
Study type: Observational [Patient Registry]

This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.

NCT ID: NCT04230681 Completed - Clinical trials for Obstructive Sleep Apnea

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Start date: February 26, 2020
Phase: Early Phase 1
Study type: Interventional

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

NCT ID: NCT04221009 Completed - Clinical trials for Sleep Apnea, Obstructive

Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury

FISATABI
Start date: August 3, 2020
Phase: N/A
Study type: Interventional

Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental health, poor physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces the many negative health consequences of the disease. However, adherence to PAP is required to reap the therapeutic benefit. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is part of the standard of care for OSA treatment with PAP, but on its own is insufficient for improving PAP adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to increase PAP use and improve PAP adherence in persons without TBI. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel 4-session manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA. Study Aims: Study Aim 1 will test the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process measures. To date, no treatment exists to ameliorate the adverse consequences of moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI, which is a leading cause of long-term disability. Method: In this study, 19 Veterans will be recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) will be invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention. Adherence will be measured via objective data from hospital software which monitors PAP use.