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Apnea clinical trials

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NCT ID: NCT05980936 Recruiting - Clinical trials for Obstructive Sleep Apnea

Screening for Obstructive Sleep Apnea in Medical Patients

Start date: October 15, 2023
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is highly prevalent in the general population and is associated with multiple adverse cardiovascular consequences. Screening for OSA is recommended in those with typical symptoms, such as daytime sleepiness, loud snoring, or abrupt awakenings with gasping or choking. Patients admitted to the general medical wards with these symptoms will be evaluated for the possibility of having OSA.

NCT ID: NCT05955287 Recruiting - Sleep Apnea Clinical Trials

CPAP Adherence Pilot Study Among African Americans

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The goal of the study is to determine the feasibility of a behavioral intervention to improve CPAP adherence among African American patients with obstructive sleep apnea.

NCT ID: NCT05954026 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Use of the ExVent Accessory With the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The ExVent is an optional accessory to the O2Vent Optima MAD and provides oral Expiratory Positive Airway Pressure (EPAP). Oral EPAP with the ExVent is designed to provide upper airway support via similar mechanisms of action of nasal EPAP devices in commercial distribution, e.g., passive dilatation of the airway, which reduces flow limitation. Nasal EPAP devices are in commercial distribution as stand-alone therapies for the treatment of OSA. The oral EPAP provided by the ExVent accessory is designed to augment the OSA therapy provided by the O2Vent Optima.

NCT ID: NCT05953610 Recruiting - Clinical trials for Obstructive Sleep Apnea

Endotypic Traits and Obstructive Sleep Apnea Surgery

Start date: January 7, 2024
Phase: Phase 2
Study type: Interventional

This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).

NCT ID: NCT05949164 Recruiting - Clinical trials for Obstructive Sleep Apnea

The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children

IPAd
Start date: May 16, 2023
Phase:
Study type: Observational

Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. However, the presence of insomnia in children with known SDB as well as its impact on PAP adherence have not been explored. This proposal will explore the association of coexisting insomnia on PAP adherence in children with SDB using a cross-sectional study design. The investigators will assess the association between insomnia and PAP therapy adherence, measured as the mean minutes of nightly PAP usage over 6 months of use on objective downloads.

NCT ID: NCT05933603 Recruiting - Clinical trials for Obstructive Sleep Apnea

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

MOSAIC
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.

NCT ID: NCT05928923 Recruiting - Clinical trials for The Screening and the Treatment of ECG Holter and Sleep Apnea

The Screening and the Treatment of ECG Holter and Sleep Apnea

Start date: April 16, 2020
Phase: N/A
Study type: Interventional

Sleep quality affect working and learning performance; poor quality of sleep is one of the common problems of modern people. Traditionally, polysomnography is a recognized standard for sleep quality assessment. Subjects are put adhesive electrodes, chest and abdomen band, oximetery, and oronasal cannula and stay in certified sleep laboratory for monitoring. These sensors setup are cumbersome and be likely to induce discomfort. An alternative to assess the quality of sleep is actigraphy, which allows users to wear for more than two weeks. In recent years, many of the devices, which often measure physiological signals, are prevailing to make long-term sleep monitoring feasible, but its accuracy and effectiveness still need to be verified. Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. OSA is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which results in the negative impact on prognosis. PSG is the gold standard for OSA diagnosis which is expensive and less accessible. Therefore, modality other than PSG is necessary to speed up diagnosis and treatment. Center of Sleep Disorder in National Taiwan University Hospital has been operated since June 2006. Up to Dec.2015, totally 8,819 patients have been referred for sleep studies (NTUH cohort) where 1,435 patients are under long-term CPAP and 396 patients are under MAD. Using data from 4,618 patients in NTUH cohort, we have already established an OSA prediction mode (apnea-hypopnea index, AHI≥5/hr) with accuracy 82.37% (sensitivity 87.03%, positive predictive value 91%). Regarding the molecular mechanism, our previous study showed that by plasma metabolomics profiling, we could identify candidate metabolites associated with OSA severity. The 11 candidate metabolites were identified by comparing profiling in 100 patients with AHI <15/hr and with AHI≥ 15/hr, respectively. Six identified metabolites were selected to establish an AHI prediction model which gave sensitivity 66%, specificity 72%, and AUROC 0.736. Furthermore, 15 plasma metabolites associated with excessive daytime sleepiness (EDS) or polysomnographic parameters were identified. Among those metabolites, L-Kynurenine and g-Glutamylleucine were metabolites associated with EDS which generated the AUROC to EDS prediction as 63% in study group and 76.7% in validation group. The "LARGAN"ECG Holter for diagnosis of sleep disorder has been set up by LARGAN-health. It aims on population with simple diagnosis of sleep disorder. Combining the "LARGAN"ECG Holter provides the diagnosis and solution of sleep disorder, sleep tracking, and education. This devices is almost set and needs the input from general population to validate the accuracy. The trial, which includes questionnaires, Actigraph devices, 24-hr BP and "LARGAN"ECG Holter for long-term home sleep monitoring, is proposed to allow users to detect potential subjects who have sleep disorders by using the ECG Holter. The aims of the present project include: (1) All 190 voluntary. Recruit 30 voluntary participants from patients with mild OSA (AHI≥5-15/hr), 160 for each voluntary participants from patients with moderate OSA (AHI≥15-30/hr) and severe OSA (AHI≥30/hr) to validate agreement of sleep efficiency via this trial, Actigraph devices and ECG Holter for 9 days, and 24 hour blood pressure for one day. (2) All participants will take an overnight PSG test, blood sampling, basal metabolism measurement, Actigraph devices, ECG Holter, body composition and E-Prime at the sleep center to validate the performance of this system on diagnosis of OSA in low risk population. (3) Analyze the of PSG parameters in both low and high risk population (to build up the out of center devices for OSA home testing). (4) Integrate the clinical parameters and plasma metabolic profile, before and after treatment, to identify factors associated with OSA related sequels and long-term prognosis.

NCT ID: NCT05918120 Recruiting - Hypertension Clinical Trials

Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

SUPER-SHARP
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

Uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. Obstructive sleep apnea (OSA) is common in hypertension and treatment using continuous positive airway pressure (CPAP) has been shown to effectively lower blood pressure. Despite its clinical significance, OSA remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose OSA is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. An alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. The objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. The investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of OSA diagnosis and treatment using CPAP, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. The investigators will also assess whether home testing is cost-effective.

NCT ID: NCT05917119 Recruiting - Clinical trials for Obstructive Sleep Apnea

Bright Light Therapy for OSA

BrightDaysII
Start date: February 8, 2024
Phase: N/A
Study type: Interventional

Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.

NCT ID: NCT05911737 Recruiting - Clinical trials for Concentration Ability Impaired

Ocular Parameters in Patients With Sleep Apnea

Start date: July 1, 2022
Phase:
Study type: Observational

The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)