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Apnea clinical trials

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NCT ID: NCT05445869 Terminated - Clinical trials for Obstructive Sleep Apnea

Severe OSA Study (SOS)

Start date: September 12, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.

NCT ID: NCT05435001 Completed - Clinical trials for Sleep Apnea Syndromes

Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSAS) is a growing health concern affecting up to 60 % of population with cardiovascular disease. Despite the high cardiovascular morbidity and mortality associated with this syndrome, the substantial inconvenience and cost of polysomnography recordings may delay routine evaluation. Polysomnography (PSG) is the gold standard for diagnosis. However, this is a costly and time-consuming examination. Sympathoadrenergic balance obtained from the routine Holter monitoring suggesting the presence of OSAS, can enable patients to be guided and their PSGs to be primarily held.Abnormalities in nocturnal cyclical heart rate (HR) variations have previously been described in sleep-related breathing disorders. Compared with PSG, holter electrocardiogram has the advantages of pervasion, lower cost, no need for overnight hospitalization, greater similarity to normal conditions, and good compliance. The observation of changes in heart rate associated with apneic events has a potential to be used as an alternative technique for identification of subjects with OSAS. In regard to the feasibility of screening OSAS by HRV analysis by holter electrocardiogram monitoring, it has already been reported that a 24-h electrocardiographic monitoring might be useful to diagnose OSAS. It became a more feasible technique to use following the development of a convenient recorder for OSAS screening by analyzing changes in heart rate.

NCT ID: NCT05433883 Enrolling by invitation - Clinical trials for Mild Cognitive Impairment

The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness

OSA
Start date: November 3, 2020
Phase: N/A
Study type: Interventional

The research plan to enroll 15 simple snoring patients (apnea/hypopnea <5, control group), 30 severe OSA patients (apnea/hypopnea >30, treatment group), and 15 mild cognitive impairment patients (comparative group). All patients complete Mini-Mental State Examination, peripheral blood sample for plasma Aβ42, Aβ40, Aβ42/Aβ40, Tau, NfL; amyloid deposit in18F-florbetapir PET; and Taiwan smell identification test. Thirty severe OSA patients (AHI>30, treatment group) receive comprehensive upper airway surgery with/without bariatric surgery and repeat postoperative assessment in polysomnography and aforementioned examinations 1 year later.

NCT ID: NCT05432908 Terminated - OSA Clinical Trials

Effect of Orofacial Myofunctional Therapy on Mouth Air Leak in Patients With Sleep Apnea Treated With CPAP

Start date: July 28, 2017
Phase: N/A
Study type: Interventional

To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

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: NCT05421403 Completed - Clinical trials for Obstructive Sleep Apnea

The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients

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

Objectives: Determination of the impact of obstructive sleep apnea (OSA) on the cognitive function (CF) and serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and 1β levels in children aged 5-12 years and the effect of OSA management on these variables. Patients & Methods: 224 patients were evaluated using the Pediatric Sleep Questionnaire, the NEPSY score for CF and Polysomnography (PSG) to grade OSA severity according to the Apnea/hypopnea index (AHI). Patients with adenotonsillar hypertrophy grade >2 will undergo the appropriate surgical intervention. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI). Blood samples were obtained for ELISA estimation of cytokines' levels. At end of 6-m follow-up, all variables were re-evaluated

NCT ID: NCT05420129 Suspended - Clinical trials for Obstructive Sleep Apnea

Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function

Start date: June 30, 2024
Phase:
Study type: Observational

This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment. 52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group. Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.

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: NCT05412004 Completed - Obesity Clinical Trials

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

SURMOUNT-OSA
Start date: June 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.

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.