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Sleep Disordered Breathing clinical trials

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NCT ID: NCT06292299 Not yet recruiting - Clinical trials for Sleep Disordered Breathing

The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study

PARS
Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes. This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients.

NCT ID: NCT06255613 Not yet recruiting - Arrhythmia Clinical Trials

Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score > 3, by comparing to the attended in-lab PSG, the gold standard. Secondary Objectives: To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG; To assess the accuracy of the BR arrhythmia detection algorithm; To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies; To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance; To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis; To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).

NCT ID: NCT06060366 Not yet recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Impact of Pulmonary Endarterectomy on Sleep-Related Breathing Disorders in CTEPH: The IPES Trial

IPES
Start date: December 20, 2023
Phase:
Study type: Observational

Pulmonary hypertension (PH) has three main types, pre-capillary PH, post-capillary PH, and combined pre-capillary and post-capillary PH, and it is based on mean pulmonary arterial pressure (PAP) > 20 mmHg measured with a right heart catheterization (RHC). Chronic thromboembolic pulmonary hypertension (CTEPH) is mainly defined as a pre-capillary PH and classed as a Group IV PH. It was reported that 0.1-9.1% of individuals with pulmonary embolism develop CTEPH within two years after the initial diagnosis, and CTEPH is the only PH category that has a chance of being cured, mainly by pulmonary endarterectomy. Sleep-related breathing disorders (SRBD) are defined as obstructive sleep apnea (OSA) disorders, central sleep apnea (CSA) syndromes, sleep-related hypoventilation disorders, and sleep-related hypoxemia. An SRBD may also lead to an increase in PAP primarily during sleep and cause nocturnal hypoxemia. Although SRBDs were reported in patients with pre-capillary PH, most of the studies included patients with idiopathic PAH. Although the cause-and-effect relationship between pre-capillary PH and SRBDs is uncertain, it is known that mPAP may increase during sleep in patients with OSA . Less is known regarding the occurrence of SRBDs in CTEPH. Previously a few study showed relationship between SRBDs an CTEPH as the main type was OSA. Most of the studies evaluated preoperative occurance and incidance of SRBDs in CTEPH. Only one study performed post operative SRBD on a cardiorespiratory device was conducted the night before and one month after elective pulmonary endarterectomy. In our previous study we showed that severe nocturnal hypoxemia (NH) is highly prevelant in preoperative CTEPH patients and the most common two types of SRBD are OSA and isolated sleep related hypoxemia (ISRH) and age, mPAP and AHI are independent determinants of severe NH. (J. Clin. Med. 2023, 12, 4639 https://doi.org/10.3390/jcm12144639) In this present study we aimed to investigate occurrence of SRBDs and mortality 5 years after pulmonary endarterectomy operation.

NCT ID: NCT05547477 Not yet recruiting - Asthma in Children Clinical Trials

Continuous EMG Measurements in Children With Asthma During Sleep

Start date: September 2022
Phase:
Study type: Observational

The objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.

NCT ID: NCT05462834 Not yet recruiting - Glucose Intolerance Clinical Trials

Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations. The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.

NCT ID: NCT04120428 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

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

Obstructive sleep apnea syndrome (OSAS) is defined as a total cessation of upper airway flow for at least 10 seconds. OSAS is considered under diagnosed and it is assessed by a full-night sleep polysomnography. Continuous positive airway pressure (CPAP) is considered the first line treatment to OSAS, however physical exercise has emerged as an adjunct and/or alternative strategy to CPAP in OSAS patients.

NCT ID: NCT01734460 Not yet recruiting - Clinical trials for Sleep Disordered Breathing

Maternal Sleep Disordered Breathing and Fetal Growth

Start date: January 2013
Phase: N/A
Study type: Observational

Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with serious neurocognitive, metabolic and cardiovascular consequences that has a significant impact on public health. Evidence indicates that the physiologic changes occurring during pregnancy, particularly during the third trimester, increase the risk of those women to develop SDB. As in the general population, SDB during pregnancy is more frequent among obese women. In the light of the increasing prevalence of obesity among females of reproductive age, SDB may thus have an increasingly significant impact on women's and children's health by contributing to the adverse maternal and fetal outcomes associated with maternal obesity. Only a limited amount of data is available on the consequences of maternal SDB during pregnancy. Even less information is available on the effect of maternal SDB on fetal growth and development. The current proposal is designed to specifically explore the effect of maternal SDB on fetal growth. It has been suggested that fetal growth as reflected in birth weight is a strong correlate for conditions occurring in the intrauterine environment with potential long lasting influence on a child's health. Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the metabolic alterations associated with maternal SDB will affect fetal growth. Using a variety of methods and a multidisciplinary approach, we will explore the following objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3 years of life) effect of maternal SDB on a child's growth. The results of this study will make an important contribution to the fields of women and children's health. It will provide better insight into the mechanisms by which disrupted maternal sleep affects fetal growth. We expect that the findings from our study will enable the defining of a new treatable clinical entity or syndrome: "the infant of the gestational SDB mother", for which early diagnosis and intervention might be of major importance to the newborn infant.