Clinical Research Directory

Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Level 3 Validation Study

This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.

A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a frequent illness related to sleep and breathing with many symptoms and complications. The primary choices of treatment are continuous positive airway pressure (CPAP) and removable appliance for protruding the mandible when sleeping (MAD). Treatment with CPAP is superior to treatment with MAD but many patients don't tolerate CPAP why they seek treatment with MAD. In Denmark, treatment with MAD is not free of charge unlike treatment with CPAP and MAD is therefore not offered systematically to the patients. The same applies to adjustment, control and effect of the MAD treatment. MAD treatment has a positive effect on OSA in general but the effect varies due to differences in selection of patients and lack of specifying who performs and evaluates MAD treatment, the effect on sleep and possible side effects in muscles and the temporomandibular joint as well as the occlusion during treatment. It is therefore of great importance to investigate the effect of MAD treatment as well as short- and long-term side effects. The aim is therefore to compare the treatment effect of MAD and CPAP and how significant the investigation of the airways and the face is for the treatment effect and possible side effects. The project is a 4-year investigation and 70 adult patients diagnosed with moderate OSA are included. The results from the investigation will be of great importance for the choice of treatment and prognosis for the individual patient and socio-economic since the treatment of OSA could be tailored the individual patient and the treatment effect optimised.

Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test

The predictors of objective impaired alertness assessed by Maintenance of Wakefulness Tests (MWT) are poorly understood. Identifying such predictors are essential from a clinical point of view and from a pathophysiological perspective, to better understand the determinants of residual Excessive Daytime Sleepiness (EDS) and the complex link between subjective and objective impairments. Also, the objective of this study is to describe psychological but also sociological and professional factors associated with Maintenance of Wakefulness Tests results.

Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

This is a prospective, cross-sectional observational study designed to evaluate the Pediatric Sleep Questionnaire (PSQ) as a screening tool for sleep-disordered breathing (SDB) risk in a pediatric dental setting. Children aged 8-13 years will be classified as low- or high-risk for SDB based on PSQ scores and compared using physiologic sleep parameters obtained from a wearable, FDA-cleared home sleep monitoring device, alongside psychosocial assessments and craniofacial measurements derived from lateral cephalometric radiographs. Findings will inform the feasibility and accuracy of incorporating validated SDB screening into routine pediatric dental care.

Fractional Exhaled Nitric Oxide as Possible Non - Invasive Biomarker to Assess Obstructive Sleep Apnea Severity

Aim of work 1. Primary aim: Asses correlation between FeNO level, OSA severity 2. Secondary aim: Clarifying FeNO's role as a biomarker to assess airway inflammation, Cut off value prediction to moderate and severe OSA and its potential significance to improve clinical management strategies for OSA patients.

The Impact of Volume Overload on Obstructive Sleep Apnea in Patients With Congestive Heart Failure

The goal of this observational study is to learn how removing extra fluid from the body (diuresis) affects sleep apnea in adults hospitalized with heart failure. The main questions it aims to answer are: Does sleep apnea severity improve after fluid removal? Is the improvement in sleep apnea related to the amount of fluid removed? Do changes in neck size reflect changes in sleep apnea severity? Participants admitted to the hospital with heart failure and fluid overload will take part in this study. Participants will: Use a wearable sleep monitoring device (WatchPAT) on the first night of hospitalization Use the device again after fluid removal, when the treating cardiologist determines that the patient is no longer fluid overloaded Have their neck circumference measured before and after fluid removal Have their weight and fluid balance recorded during hospitalization Have routine blood tests and clinical assessments as part of standard care Researchers will compare each participant's results before and after fluid removal to see if sleep apnea improves and whether these changes are linked to fluid removal and changes in neck circumference.

CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children

This study is looking at two different treatments for obstructive sleep apnea (OSA) in children. OSA is a sleep condition where breathing repeatedly stops and starts during sleep, which can affect a child's health, behavior, learning, and quality of life. Children with moderate-to-severe OSA who cannot be treated with surgery are often prescribed Continuous Positive Airway Pressure (CPAP). CPAP uses a mask worn during sleep to deliver pressurized air and keep the airway open. Although CPAP is effective, many children have difficulty using it regularly because it can feel uncomfortable or hard to tolerate. This study compares CPAP with another treatment called High-Flow Nasal Cannula (HFNC). HFNC delivers warm, humidified air through soft nasal prongs and may be more comfortable and easier for children to use while still helping keep the airway open during sleep. Children aged 2 to 18 years with moderate-to-severe OSA will be randomly assigned to use either CPAP or HFNC at home during sleep for 3 months. The study will measure how much each treatment is used, how well it improves sleep-related symptoms and quality of life, how comfortable it is for children, and how it affects caregivers. The goal of this study is to find out whether HFNC is a comfortable and effective alternative to CPAP for treating obstructive sleep apnea in children.

Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea

This study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing obstructive sleep apnea

IOA Preventing Occlusal Changes With MAD Use

This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite. Participants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes. The study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.

Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing

This study aims to determine the effect of adenotonsillectomy (AT) surgery on the progression of spinal curvature in children with mild sleep-disordered breathing (SDB) and concurrent scoliosis, as well as its potential role in preventing the de novo development of scoliosis in children with SDB.

Direct Referral for Apnea Monitoring

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).

High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients

Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.

Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.

The goal of this randomized clinical trial was to evaluate the effects of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i) on sleep and cardiac outcomes in adults with heart failure (HF) and obstructive sleep apnea syndrome (OSA). The study also examined how subsequent initiation of continuous positive airway pressure (CPAP) therapy affected sleep and cardiac outcomes, and whether response to treatment differed according to baseline obstructive sleep apnea severity. The main questions it aims to answer were: * Does empagliflozin affect sleep apnea severity and nocturnal oxygenation before CPAP initiation? * Does prior empagliflozin treatment influence the response to subsequent CPAP therapy? * Does empagliflozin affect oxidative stress markers, including total oxidative status (TOS), total antioxidant status (TAS), and oxidative stress index (OSI)? * Does CPAP therapy initiation affect cardiac outcomes in both groups? * Does response to treatment differ according to baseline obstructive sleep apnea severity, including mild, moderate, and severe disease? Researchers compared participants receiving empagliflozin in addition to background HF therapy with those continuing background HF therapy without empagliflozin to evaluate the effects of empagliflozin. Participants: * Were randomly assigned to receive empagliflozin plus background HF pharmacotherapy or background HF pharmacotherapy therapy without empagliflozin * Underwent sleep studies, transthoracic echocardiography and clinical assessments at baseline, 3 months, and 6 months. * Provided blood samples for measurement of cardiac biomarkers and oxidative stress markers. * Completed standardized questionnaires assessing sleep quality and symptoms. * Initiated CPAP therapy after 3 months and continued treatment until the end of the study.

Endotype DIrected Treatment for OSA in Down Syndrome

Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking ("cognitive impairment"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin ("ato-oxy") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA. The research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.

Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy

The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe obstructive sleep apnea (OSA) who are currently using positive airway pressure (PAP) therapy. This study will assess the impact of GZR18 on OSA-related symptoms, respiratory parameters, and quality of life compared to placebo.

Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.

Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea who are unable or unwilling to undergo positive airway pressure (PAP) therapy.

Personalised Active Self-management of Sleep Apnea Program

This study is to assess the feasibility and acceptability of the PASS in patients with OSA. Second, the study examines its effectiveness in improving PAP uptake and adherence, self-efficacy in self-care, changes in health-related habits, and health outcomes. We also assess the facilitators and barriers to implementing the PASS. This is a two-group pilot randomized controlled trial (n=60) with a 4-month follow-up. Subjects assigned to the intervention group will receive a 4-month Personalized and Adaptive Sleep Support (PASS) program, a digital platform-based intervention. The 4-month program incorporates: i) a 20-minute brief motivational interviewing session; ii) a digital platform where users can view personalized OSA health-related videos and information, track their adherence to prescribed treatments, log their daily activities and dietary intake, and set personal health goals; and iii) continuous personalized chat-based messaging and phone call support. Participants in the control group will receive a 4-month general hygiene program, including (i) a 20-minute session, (ii) messaging, and (iii) phone call support. The feasibility and acceptability of the PASS will be evaluated via semi-structured interviews at the 4-month follow-up. Self-administered questionnaires will be used at baseline, 2 months, and 4 months, and objective assessment tools (such as sleep tests) will be used at baseline and at the 2- and 4-month follow-ups. PAP adherence data will be downloaded from PAP machines (if available) for all subjects in both groups at baseline and at month 4.

Digital-supported Orofacial Myofunctional Therapy in OSA

This pilot study explores the feasibility, acceptability, and preliminary effectiveness of Digital-supported Orofacial Myofunctional Therapy (d-MFT), an innovative program combining facial recognition technology with evidence-based orofacial exercises for individuals with mild to moderate obstructive sleep apnoea (OSA). The d-MFT program aims to strengthen oropharyngeal muscles, improve airway function, and reduce OSA severity. Participants receiving 3-month d-MFT (n=30) are expected to demonstrate greater improvements in OSA severity, sleep-related symptoms, and quality of life compared to those in the waitlist control group (n=30). Feasibility and acceptability will be evaluated through outcome-based questionnaires and semi-structured interviews to explore participants' experiences, satisfaction, and perceived barriers to adherence.

Effects of Frequency Adjustment in Functional Electrical Stimulation on Genioglossus Muscle Activity

This single-group interventional study investigates the safety and physiologic effects of functional electrical stimulation (FES) applied to the tongue and submental muscles in adults at high risk for sleep apnea. Participants will receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order during a single visit. Ultrasound and tongue pressure (IOPI) measurements, as well as subjective assessments of discomfort and perceived effects, will be conducted before, during, and after stimulation. The primary objective is to evaluate changes in muscle thickness, length, and tongue strength across different stimulation frequencies. Secondary objectives include assessing participant discomfort, safety, and subjective treatment effects.

Telemonitoring With CPAP in Severe Obstructive Sleep Apnea in Primary Health Care

Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with cardiovascular, metabolic, cognitive, and psychological complications. Continuous Positive Airway Pressure (CPAP) therapy is the gold standard treatment for moderate to severe OSA; however, long-term adherence remains a major challenge, particularly in real-world primary care settings. This study aims to evaluate the effectiveness of telemonitoring using CPAP devices in improving treatment adherence and clinical outcomes among patients with severe OSA receiving care within the Brazilian Primary Health Care system. This randomized controlled trial will include 200 adult participants with severe OSA who are new users of CPAP therapy and are followed by primary health care units in the Southeast Regional Health Coordination of São Paulo, Brazil. Participants will be randomly allocated into two groups: a telemonitoring intervention group, monitored remotely through the AirView® platform and the myAir® application, and a control group receiving standard care without telemonitoring. Primary outcomes include CPAP adherence and residual apnea-hypopnea index (AHI). Secondary outcomes include daytime sleepiness, sleep quality, mood, cognitive complaints, and patient perceptions of care. Quantitative clinical data will be collected through CPAP telemonitoring systems and standardized questionnaires, while qualitative data will be obtained through semi-structured interviews with patients and health professionals. The results of this study may provide evidence supporting the integration of digital health technologies into primary health care services to improve adherence to CPAP therapy and optimize the management of obstructive sleep apnea in public health systems.

Multimodal Deep Learning Model for Predicting the Apnea-Hypopnea Index in Obstructive Sleep

This study aims to develop a multimodal deep learning model that integrates noninvasive signals to predict the severity of obstructive sleep apnea. By establishing a clinically viable and user-friendly monitoring tool, the study seeks to enhance early screening accessibility and support the development of home-based sleep care systems.