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Sleep Apnea, Obstructive clinical trials

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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: NCT05458193 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

Start date: August 17, 2022
Phase: Phase 1
Study type: Interventional

A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).

NCT ID: NCT05457127 Not yet recruiting - Schizophrenia Clinical Trials

Obstructive Sleep Apnea Treatment in Serious Mental Illness

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.

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: NCT05440279 Completed - Clinical trials for Obstructive Sleep Apnea

Effects of Telemedical Support on Therapeutic Results of CPAP Patients

Start date: February 19, 2019
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a type of sleep-related breathing disorders that is characterized by a sleep-related constriction (obstruction) of the upper airways. The treatment with continuous application of positive airway pressure (CPAP) via respiratory mask forms the therapeutical standard of OSA. The autoCPAP (automatic positive airway pressure: APAP) therapy is an additional treatment option for patients with more unstable conditions (e.g. due to sleep position) which is characterized by a dynamic adaption of the applied airway pressure according to patients therapeutical needs. Device usage time and therapy adherence are crucial for treatment success. The purpose of this study is to assess the effect of a digital patient support (DPS) tool, complementary to standard care on continuous and automatic positive airway pressure (CPAP, APAP) adherence and daytime sleepiness after 12 weeks in patients diagnosed with severe obstructive sleep apnea (OSA). All patients with apnea-hypopnea index (AHI) ≥ 30 per hour are prospectively included and randomized to receive standard care (SC) or standard care with personalized DPS via prisma APP prototype version (SC+DPS). In both arms, initiation of therapy and standardized therapy control after 12 weeks is carried out identically. Patients in the SC+DPS arm received additionally automated feedback on their therapy and motivational messages, as well as therapy recommendations.

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: NCT05432102 Recruiting - Clinical trials for Obstructive Sleep Apnea

Patient Experience and Technical Success of Community Sleep Studies

PETSOCSS
Start date: May 4, 2022
Phase:
Study type: Observational

This study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (OSA) by patients in their own homes. These are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. This study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.

NCT ID: NCT05429983 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics

Start date: November 29, 2022
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy. Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI <20.

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: NCT05421754 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

ANNE Diagnostic Agreement With Home Sleep Testing

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

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).