Clinical Research Directory

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.

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.

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.

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.

The Improving Sleep in African American Couples Study (ISAAC)

The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.

Evaluation of the Diagnostic Capacity of a Smart Mattress Versus Conventional Polysomnography

This project aims to develop and evaluate an innovative, non-invasive diagnostic system based on a smart mattress for detecting obstructive sleep apnea (OSA), as well as assessing overall sleep quality and identifying periodic limb movements. The main goal is to improve the accuracy of sleep apnea diagnosis while providing a less invasive solution suitable for home use, ultimately enhancing patients' quality of life. A descriptive, observational, prospective study will be conducted to analyze data obtained from diagnostic polysomnographies performed at the Sleep Unit of San Pedro Hospital between November 17, 2026, and March 1, 2028. Patients will use the smart mattress, and its measurements will be compared with polysomnography results. This comparison will allow for the optimization of the mattress's artificial intelligence, training it to accurately recognize respiratory patterns and sleep-related events, including positional apneas and periodic limb movements. Key technical objectives include: Determining the sensitivity, specificity, and predictive values of the mattress in detecting apneas, hypopneas, and limb movements compared to polysomnography. Evaluating the agreement between the mattress and polysomnography for sleep variables such as total sleep time, sleep efficiency, sleep stages, micro-arousals, and patient position. Assessing whether measurement accuracy varies by sleeping position or age group (adults vs. children). Measuring subjective sleep quality using the Groningen Sleep Quality Scale (GSQS-8). Performing a descriptive analysis of patient demographics. Hypotheses: The smart mattress will detect obstructive sleep apnea, sleep quality, and periodic limb movements with accuracy comparable to polysomnography. The system will provide a reliable, non-invasive, home-friendly diagnostic method. Measurements of the apnea-hypopnea index (AHI) and limb movements will show high sensitivity, specificity, and predictive values, both overall and according to OSA severity. There will be good agreement between mattress measurements and polysomnography for most sleep variables. Accuracy may vary depending on the patient's sleeping position. Measurements will correlate well across adults and pediatric patients. Subjective sleep quality scores (GSQS-8) will be consistent with objective mattress data. This project seeks to develop a more accurate, accessible, and non-invasive diagnostic system for OSA, combining advanced technology with ease of home use. By training the mattress's AI to recognize sleep patterns and events, it aims to optimize the detection of positional apneas, providing patients with better monitoring, early intervention, and improved quality of life.

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.

Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea

Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy

Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea

Obstructive Sleep Apnea (OSA) is one of the most prevalent sleep disorders, affecting nearly one billion people worldwide. It is characterized by repeated episodes of complete (apnea) or partial (hypopnea) obstruction of the upper airway during sleep, leading to snoring, excessive daytime sleepiness, insomnia, morning headaches, nocturia, behavioral changes, reduced concentration, and serious cardiovascular and metabolic complications such as insulin resistance, type II diabetes, and metabolic syndrome. During the night, patients may experience up to a hundred apnea or hypopnea events lasting from 10 to 120 seconds. Therapy for OSA depends on its severity, defined by five or more obstructive events per hour of sleep. Over the past decade and a half, oral appliances (OAs) have become the treatment of choice for mild to moderate forms of OSA due to their efficacy and comfort. For this purpose, the DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) has been designed with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep. Unlike conventional OAs that fix the mandible in only one propulsive position, causing stress to orofacial complex and upper airway structures such as masticatory muscles and the temporomandibular joints, the DPOA provides gradual, automatic mandibular movement to the previously determined propulsive position. This gradual adaptation minimizes stress, reduces side effects, and enhances treatment success. In that way, the DPOA enables complete functional adaptation of the orofacial system and upper airway structures, leading to improved patient comfort and better therapeutic outcome. The primary objective of the study is to determine the effectiveness of OSA therapy in patients with skeletal Class I (eugnathic jaw relationship) using a DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep.

The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy

This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.

Low-Tech Treatments for Obstructive Sleep Apnea

The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.

Study of Min-Max APAP Recommender Tool

Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients. The model takes as inputs from patient variables (e.g., baseline AHI, gender, weight/BMI, mask interface type), and outputs recommended AutoSet minimum and maximum pressure settings (cmH₂O) tailored for that patient phenotype. The intended clinical role of the Pressure Match tool is to assist the clinician's choice of AutoSet pressure range when initiating CPAP therapy, with the goal of reducing clinician time/effort in manual titration and follow-up adjustments without compromising safety, efficacy or patient satisfaction. The purpose of this trial is to test Pressure Match in a clinical trial setting, to demonstrate non-inferiority against standard APAP settings.

Wearable Device to Promote CPAP Adherence in Obstructive Sleep Apnea (OSA) Patients

The goal of this study type: clinical trial is to evaluate adherence for CPAP used with wearable device in OSA patients comparing with controlled group; could include any of the following: adult patients (≥ 19 yr of age) with moderate to severe OSA (AHI ≥ 15 events/hr by polysomnography (PSG), according to the American Academy of Sleep Medicine, diagnosed at the sleep clinic in Ramathibodi hospital, patients with OSA who are first time to prescribed CPAP treatment and in the waiting process for their machine. The main question it aims to answer is: Could a wearable device help increase the adherence of CPAP in obstructive sleep apnea patients? Primary outcome is adherence for CPAP: time usage per day(min) and % usage \> 4 hours Secondary outcome are access sleepiness and quality of sleep by questionnaire (ESS and PSQI) in Thai version, the correlation between wearable-derived and CPAP data: Total sleep time(min), sleep stage (light, deep and REM), and health information: heart rate, oxygen saturation, stress, sleep score and step counting If there is a comparison group: Researchers will compare wearable group and control group to see the effect of wearable to increase adherence of CPAP used. Participants will * Divide into two group by randomization using 4 block randomization * In wearable group, the participants will receive wearable and download application, they allow to access all the time * In control group, the participants will receive wearable and download application, but they will not allow to access until they come to hospital for follow up at the end of the study

Impacts of Opioids on Respiratory Drive During Sleep

The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.

Ultrasound Assessment of Tongue Characteristics in Children and Adolescents With Obesity

This longitudinal observational study aims to validate ultrasound-based tongue markers related to tongue characteristics, including fat accumulation, morphologic and mechanical properties of the tongue in children and adolescents with obesity. Participants are assessed at baseline and after completion of a standardized 30-week inpatient weight-loss rehabilitation program at the Zeepreventorium (De Haan, Belgium). Tongue ultrasound parameters are examined in relation to anthropometric characteristics and obstructive sleep apnea condition.

Portable Sleep Monitors in Children With Autism Spectrum Disorder

The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to: 1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG); 2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA); 3. Evaluate patient and family preferences for sleep testing.

CPAP Therapy and Atrial Fibrillation Recurrence in OSA

Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited. This prospective cohort study aims to evaluate the association between objective CPAP adherence and the risk of AF recurrence in patients with moderate-to-severe OSA and a history of paroxysmal AF. Patients will be followed for 12 months, with AF recurrence assessed using electrocardiography and Holter monitoring.

CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial

Obstructive sleep apnea (OSA) is a prevalent condition that significantly impacts the sleep health and overall well-being of millions of adults worldwide. It is characterized by breathing difficulties during sleep caused by an obstructed upper airway, leading to fragmented sleep, oxygen deprivation, and increased sympathetic activity. OSA and its associated health problems contribute to an annual economic burden exceeding $150 billion in the United States. Studies have shown that individuals with OSA are 26% more likely to develop cognitive impairment compared to those without the condition. However, despite the effectiveness of continuous positive airway pressure (CPAP) therapy, many patients struggle with acceptance and adherence to this treatment. As an alternative, mandibular advancement devices (MADs) have gained acceptance among OSA patients by improving upper airway anatomy through repositioning of the jaw and tongue, thus reducing collapsibility. This non-invasive approach shows promise, particularly in addressing the unique craniofacial features commonly found in East Asian OSA patients. To further investigate the efficacy of MAD versus CPAP therapy, a multi-center, randomized clinical trial is proposed. The trial aims to evaluate cognitive function using established assessment tools and explore the relationship between different Asian ethnicities and changes in cognitive function, ambulatory blood pressure, and cerebral oxygen saturation. Additionally, brain MRI will be utilized to examine whether baseline brain structure and function can predict treatment response in OSA patients. Participants diagnosed with moderate-to-severe OSA will be randomly assigned to either the MAD or CPAP group in a 1:1 ratio. Baseline assessments, along with six-month and one-year follow-ups, will be conducted to assess the impact of the interventions. This trial seeks to provide valuable insights into the effectiveness of MAD versus CPAP therapy in Asian populations, specifically focusing on their effects on cognitive function and other relevant outcomes in individuals with OSA.