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Sleep Disordered Breathing clinical trials

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NCT ID: NCT06154577 Recruiting - Clinical trials for Obstructive Sleep Apnea

Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

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

Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm. During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.

NCT ID: NCT06043830 Recruiting - Chronic Pain Clinical Trials

Managing Opioid Related Sleep Apnea With Acetazolamide

MORPHO
Start date: October 18, 2023
Phase: Phase 2
Study type: Interventional

Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. However, this device is not effective or tolerated in all individuals. The goal of this study is to examine whether a medication called acetazolamide can improve SDB, as an alternative to CPAP treatment. The investigators will measure the improvement in SDB, as well as any change in symptoms, during a 1 week treatment with acetazolamide compared with 1 week of placebo (sugar pill). This study will help to provide data for longer term studies of treatment for SDB in patients who use opioids.

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: NCT05908591 Recruiting - Pregnancy Related Clinical Trials

Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy

SLEEP
Start date: January 1, 2023
Phase:
Study type: Observational

This is a prospective longitudinal cohort study whereby pregnant individuals are asked to complete an 8-day testing protocol to measure their sleep and cardiovascular health at two timepoints during pregnancy.

NCT ID: NCT05881031 Recruiting - Clinical trials for Sleep-Disordered Breathing

Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

Children with medical complexity (CMC) often have trouble breathing at night and need to use a breathing machine. This breathing machine is called noninvasive positive pressure ventilation (NiPPV). The use of NiPPV has been shown to improve quality of life and survival in children. Before it is used, NiPPV must first be tested to see what the correct 'machine settings' are for each child. This is usually done in the sleep laboratory at the hospital during a one-night stay. However, sleep studies in the hospital are disruptive and hard for CMC and their families because of the new environment and limited access to the equipment, supplies, comfort items and the routine their child has at home. Patients and families would prefer to start NiPPV at home but there needs to be more research on this to make sure it is possible and safe. This study will evaluate a new model of care to start NiPPV in the home. CMC aged 5-17 years old and starting NiPPV will be assigned at random, like a coin toss, to start NiPPV in the home or to start NiPPV in the sleep laboratory. The investigators will assess the feasibility and safety of the two ways to start NiPPV. This study will be the first step towards developing a study to evaluate if home NiPPV starts are effective. Starting NiPPV at home has the potential to improve the use of NiPPV (ie early adherence predicts long-term use) resulting in both medical benefits as well as improved quality of life for CMC and their families.

NCT ID: NCT05661747 Recruiting - Snoring Clinical Trials

Dental Appliance to Treat SDB in Children

Start date: May 3, 2022
Phase: Phase 4
Study type: Interventional

The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.

NCT ID: NCT05656365 Recruiting - Clinical trials for Obstructive Sleep Apnea

Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders

Start date: May 23, 2023
Phase:
Study type: Observational

Background: Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the most common periodic fever syndrome of childhood. Symptoms can include swelling of the glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the periodic flareups. But researchers do not know how PFAPA develops. In this natural history study, researchers will collect specimens and data from people with PFAPA to see what they might have in common. Objective: To collect blood and other specimens from people with PFAPA to learn more about the illness. Eligibility: People aged 1 month or older with symptoms of PFAPA or another tonsil disorder. Design: Participants will be screened. Their medical records will be reviewed. Researchers will ask about a family history of PFAPA. The following specimens may be collected: Blood. Blood will be drawn either from a needle inserted into a vein or from a prick in the finger or heel. Mucus and cells. A stick with soft padding on the tip may be rubbed inside the nostrils or mouth. Stool. Saliva. Tissue samples may be taken if participants are having surgery to remove the tonsils or adenoids. Participants having surgery may also have a nasopharyngeal wash; salt water will be squirted into the back of the throat and then sucked back out with a syringe. Most participants will provide specimens only once. They can do this in person at the clinic; they can also have their local health providers send specimens to the researchers. Some participants may have optional follow-up visits over 10 years.

NCT ID: NCT05589753 Recruiting - Opioid Use Clinical Trials

Sleep Disordered Breathing With Opioid Use

SDB
Start date: May 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.

NCT ID: NCT05575401 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Start date: May 17, 2023
Phase: N/A
Study type: Interventional

The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are: - Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? - Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? - Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.

NCT ID: NCT05466864 Recruiting - Stroke, Acute Clinical Trials

Screening of OSA in Hospitalized Stroke Patients Using BSP

Start date: May 4, 2022
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke. Wearable devices can greatly reduce the manpower and material requirements of traditional laboratory-based polysomnography (PSG). With Photoplethysmography (PPG) technology and neural network algorithms, the Belun ring and the sleeping platform not only can detect blood oxygen, and heart rate but also can identify sleep stage and estimate the severity of sleep apnea. In this study, inpatients with acute ischemic stroke in the hospital will proceed with three nights test for recording the parameters of the autonomic nervous system in the acute phase, evaluate whether sleep apnea and the feasibility of the Belun sleep platform. It is important that early recognition of OSA and prompt treatment, which can potentially improve OSA-associated adverse outcomes, as well as understanding the degree of autonomic nervous function impairment for patients with acute ischemic stroke. After smoothing this process, it can help clinicians more accurately comprehend the condition, timing of admission, and discharge.