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Sleep Apnea Syndromes clinical trials

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NCT ID: NCT04575740 Recruiting - Sleep Apnea Clinical Trials

Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes. One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the "apnea-hypopnea index (AHI)", there is a potential risk of negative results. In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia ("hypoxic burden"), autonomic response ("heart rate burden"), and sleep fragmentation ("arousal burden").

NCT ID: NCT04572503 Recruiting - Clinical trials for Obstructive Sleep Apnea

Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (OSAS).

NCT ID: NCT04572269 Recruiting - Clinical trials for Obstructive Sleep Apnea

Metabolomics of Obstructive Sleep Apnea

MOSA
Start date: September 21, 2020
Phase:
Study type: Observational

This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland.

NCT ID: NCT04557293 Recruiting - Clinical trials for Obstructive Sleep Apnea

Effort-based Decision-making and CPAPadherence

Start date: March 10, 2021
Phase: N/A
Study type: Interventional

Obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. The gold standard of treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. The aim of our study is to investigate the effort based-decision making in patients with OSA, pre and post CPAP treatment, as a possible cause of poor adherence.

NCT ID: NCT04536623 Recruiting - Stroke Clinical Trials

SIESTA for Acute Stroke Rehabilitation

SIESTA-Rehab
Start date: July 20, 2020
Phase: N/A
Study type: Interventional

The SIESTA-Rehabilitation protocol combines two sleep-promoting interventions, (1) empowering nurses to reduce unnecessary disruptions and (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing, to determine its impact on relevant sleep and rehabilitation outcomes in the acute inpatient stroke rehabilitation setting compared to the standard of care. Our primary outcome is change in Quality Indicator (QI) score, a measure that has replaced the Functional Independence Measure (FIM) in the inpatient setting at the Shirley Ryan AbilityLab, between admission and discharge.

NCT ID: NCT04513483 Recruiting - Atrial Fibrillation Clinical Trials

CPAP in AF Patients With OSA

CPAPAF
Start date: August 7, 2020
Phase: N/A
Study type: Interventional

Obstructive sleep apnea is associated with atrial fibrillation. This study is to evaluate the effect of continuous positive airway pressure on the burden of atrial fibrillation in the patients with obstructive sleep apnea and paroxysmal atrial fibrillation.

NCT ID: NCT04496843 Recruiting - Sleep Apnea Clinical Trials

Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

VPASH
Start date: January 16, 2020
Phase:
Study type: Observational

Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test. Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep. The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

NCT ID: NCT04483427 Recruiting - Clinical trials for Obstructive Sleep Apnea

Multimodal Postoperative Analgesia Following OSA Surgery

Start date: September 20, 2020
Phase: N/A
Study type: Interventional

Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries

NCT ID: NCT04478201 Recruiting - Clinical trials for Obstructive Sleep Apnea

Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate

SLUMBRS2
Start date: January 28, 2022
Phase: N/A
Study type: Interventional

The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is known to influence the patency of the airway during sleep. Altering sleep position in infants with CP may offer a 'low-cost, high impact' intervention to limit the negative impacts of OSA on child development. Children with CP are at increased risk of impairment in learning, memory and cognition, with OSA representing an additional risk to cognitive development. Infants with CP are at risk of poor weight gain and 'failure to thrive', which can be further exacerbated by co-existing OSA. The design and conduct of the proposed randomised controlled trial will benefit from lessons learned from both the feasibility and other previous studies. Investigators demonstrated that existing advice given about sleep position varied significantly with some centres recommending back-lying and others side-lying. Sample size calculations were based on this multi-source data. Parents in the feasibility study knew that sleep position advice for infants with CP changes regularly. They understood why not adhering to 'national guidance' (DoH 2009, Back to Sleep) could be necessary as their infants are "different to normal infants". How will this study benefit infants with cleft palate and their parents? The proposed study will eliminate the current uncertainty and variability in advice provided to parents of infants with CP, whilst potentially limiting the negative impact of OSA on development. This work has been prioritised and received unanimous support from Cleft Lip and Palate Association (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation resulting from OSA.

NCT ID: NCT04474756 Recruiting - Apnea Syndrome Clinical Trials

Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) During Sleep

SONAR
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).