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NCT ID: NCT05489562 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

To learn whether stabilization of the tongue using intraoral suction is tolerable and what effects this approach has on sleep parameters in obstructive sleep apnea.

NCT ID: NCT05477719 Recruiting - Clinical trials for Sleep Apnea Syndromes

Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea). The main symptoms of sleep apnea-hypopnea syndrome are daytime sleepiness (caused by the fragmentation and breakdown of sleep) and nocturnal snoring; possibly accompanied by the following symptoms: non-restorative sleep, difficulty concentrating, nocturia, cognitive disorders, libido disorders. The consequences of sleep apnea-hypopnea syndrome are multiple for the patient both in the short term and in the long term. The short-term manifestations are as follows: daytime sleepiness, reduced alertness, difficulty driving (risk of road accidents), difficulty performing tasks (risk of accidents at work), memory and concentration problems , learning difficulties (especially in children), mood disorders. In the end, there is an alteration in the quality of life of the patient. Sleep apnea-hypopnea syndrome also has long-term consequences: a link between sleep apnea-hypopnea syndrome and cardiovascular morbidity and mortality has been explored by several cohort studies. Nasal ventilation by continuous positive airway pressure is considered the reference treatment for sleep apnea-hypopnea syndrome. The use of nasal ventilation by continuous positive airway pressure, compared to no treatment, is not associated with a reduced risk of cardiovascular outcomes or death in patients with sleep apnea according to a recent meta-analysis. Mandibular advancement devices are an alternative treatment for nasal ventilation by continuous positive airway pressure. The acceptability of its treatments, whether nasal ventilation by continuous positive airway pressure or mandibular advancement devices, is not very good and some patients do not start treatment or abandon it because of the constraints related to these treatments. There is therefore a need to find other treatments. The overnight rostral fluid displacement from the legs, related to prolonged sitting can generate edema in the neck, more precisely in the upper airways, and therefore obstructive respiratory dysfunctions responsible for sleep apnea-hypopnea syndrome. Correlations between nocturnal fluid shifts and the number of apneas/hypopneas have been demonstrated Previous studies has shown a reduction in the apnea-hypopnea index by the daytime preventive wearing of medical compression, which can reduce the extent of leg edema and the displacement of nocturnal fluids. The aim of the present study is to show that daytime wearing of medical compression developed specifically to optimize its effect in this indication for 28 days versus not wearing it reduces the number of apneas/hypopneas in patients with sleep apnea-hypopnea syndrome.

NCT ID: NCT05475119 Recruiting - Sleep Apnea Clinical Trials

Effect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The participants whom undergo Polysomnography study (Sleep study) and are found to have mild, moderate or severe Obstructive Sleep Apnea (OSA) will have two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.

NCT ID: NCT05471765 Recruiting - Clinical trials for Obstructive Sleep Apnea

Effects of Continuous Positive Airway Pressure Therapy Withdrawal in Patients With Obstructive Sleep Apnea: A Randomized Trial

Start date: March 23, 2020
Phase: N/A
Study type: Interventional

Study design (e.g., double-blind: A randomized, open-labeled, controlled, parallel-group study. Sixty patients will be recruited with moderate to severe Obstructive Sleep Apnea (OSA), previously adherent to CPAP therapy and have controlled OSA defined as Apnea Hypopnea Index (AHI) of < 5 while on treatment. Patients will be divided into two groups after completion of Therapeutic CPAP, Who will continue on same CPAP therapy for 4 weeks they will be randomized into two groups: 1. NO CPAP (NOCPAP Group): Who will stop using the CPAP device. 2. Intermittent CPAP (Int-CPAP Group): Who will use the CPAP device every other night. This trial will also evaluate the effects of CPAP withdrawal (complete or partial) on excessive day time sleepiness (EDS), apnea hypopnea index (AHI), Heart Rate and Blood Pressure.

NCT ID: NCT05470153 Recruiting - Clinical trials for Severe Asthma With Obstructive Sleep Apnea

The Efficacy of Continuous Positive Airway Pressure in Achieving Asthma Control in Patients With Severe Asthma and Obstructive Sleep Apnea

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Asthma is a common heterogeneous chronic disorder of the airways, characterized by variables, usually reversible and recurring symptoms related to one or more of airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. Approximately 5-10% of asthmatics have severe or difficult to treat asthma that remains problematic despite optimal treatment. Current asthma guideline recommend investigating the presence of OSA in the cases of severe or uncontrolled asthma. Obstructive sleep apnea (OSA) is a disease that characterized by frequent narrowing or collapsed of upper airways during sleep. Recent studies have shown an overlap between Asthma and Obstructive Sleep Apnea. The mechanism of interaction between OSA and asthma is complex. Moreover, the two diseases have common comorbid conditions such as GERD and obesity which negatively impact asthma control. Polysomnography is the study of sleep using different leads, heart rate and oxygen monitor to assess the architecture of the sleep. Abnormal obstructive breathing events during monitored sleep are described according to the latest recommendation of the American Academy of Sleep Medicine. For each patient with OSA, titration of CPAP pressure will be performed by conventional polysomnography or using auto-CPAP equipment using a validated protocol. The investigators aim in this study to examine the effect of CPAP treatment in severe asthma patient with concurrent moderate and severe OSA.

NCT ID: NCT05461417 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea

PANTHERA
Start date: April 7, 2022
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients. The Panthera D-SAD® is a computer aided design (CAD)/computer aided manufacturing (CAM), patient-matched, 3D printed, biocompatible nylon OAT. This five-year, observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD® orthosis on reducing the apnea hypopnea index (AHI) and obstructive sleep apnea-hypopnea syndrome (OSAHS) symptoms. Adherence, tolerance, and side effects will be evaluated. An estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of OAT, and struggles or refuses continuous positive airway (CPAP) treatment. The professional collaborative nature of the study reflects real-world clinical practice. Participants will be followed over the course of five years at the following time points. Visits include the following: Specialist in sleep disorders: (1) Inclusion, (2) 3 months, (3) 2 years, (4) 5 years. Specialist in manducatory apparatus (dentist): (1) Inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years The efficacy of the Panthera D-SAD® MAO will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial AHI, when monitored by nocturnal breathing polygraphy (NP) or polysomnography (PSG). Secondary endpoints will also be obtained at the aforementioned time points for reporting. The results of this study will fulfill regulatory requirements for reimbursement in France.

NCT ID: NCT05459935 Recruiting - Clinical trials for Obstructive Sleep Apnea

Photobiomodulation for Pediatric Hypertrophic Tonsils

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea. The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting. The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.

NCT ID: NCT05428839 Recruiting - Clinical trials for Sleep Apnea, Obstructive

The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

PREDICTOR
Start date: May 11, 2022
Phase: N/A
Study type: Interventional

This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.

NCT ID: NCT05419323 Recruiting - Clinical trials for Obstructive Sleep Apnea (OSA)

Direct Referral for Apnea Monitoring

DREAM
Start date: August 1, 2020
Phase:
Study type: Observational

The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

NCT ID: NCT05402683 Recruiting - Clinical trials for Difficult Intubation in Obstructive Sleep Apnea

Ultrasound Versus Clinical Tests as Predictors of Difficult Endotracheal Intubation in Patients With Obstructive Sleep Apnoea Undergoing Elective Surgery Under General Anaesthesia

Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Obstructive sleep apnoea (OSA) is the most serious kind of the sleep-disordered breathing group, characterised by recurrent episodes of partial to complete obstruction of the upper airway resulting in inefficient alveolar gas exchange and desaturation[1]. It is a commonly encountered condition with a reported prevalence of 9-25% in the general population [2]. However, the majority of OSA patients presenting for surgery remain undiagnosed or untreated[3], contributing to a high rate of unexpected adverse airway outcome[4]. The various airway abnormalities represented by OSA include a large tongue, collapsible airway and crowding of the oropharyngeal structures, among others[5]. Accurate airway assessment should always be performed so as to provide appropriate planning and management of expected difficult intubation, but the common clinical screening tests (Mallampati score, inter-incisor distance, mento-hyoid distance, BMI, etc ) have shown low sensitivity and specificity with a limited predictive value, especially if only a single assessment method is used[6]. Ultrasonography could be a highly sensitive and specific tool for prediction of difficult intubation in OSA patients presented for elective surgery by measuring tongue base thickness, distance between lingual arteries, hyo-mental distance and condylar mobility.