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82 Apnea Trials
Power is an online platform that helps thousands of Apnea patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Health Communication for Pediatric Obstructive Sleep Apnea
Indianapolis, IndianaThe goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:
* Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
* Does the use of a health communication message help health care systems identify more children with OSA?
Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.
In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).
Researchers will compare groups to see if the health communication message helps identify more children with OSA.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:2 - 13
Sex:All
200 Participants Needed
Retatrutide for Type 2 Diabetes and Obesity
Indianapolis, IndianaThis trial is testing retatrutide, a medication for people with type 2 diabetes who are overweight or obese, including some with sleep apnea. The medication aims to help control blood sugar levels and may also aid in weight loss.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
1000 Participants Needed
Retatrutide for Obesity
Indianapolis, IndianaThe purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
2300 Participants Needed
Nerve Stimulation Device for Obstructive Sleep Apnea
Carmel, IndianaA multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 75
Sex:All
115 Participants Needed
Genio Bilateral Stimulation for Obstructive Sleep Apnea
Carmel, IndianaThis trial tests a new device called the Genio® 2.1 System for people with moderate to severe sleep apnea. The device sends small electrical pulses to a nerve in the tongue, making it contract and keeping the airway open during sleep. The Genio® 2.1 System is part of a line of treatments involving electrical stimulation of the hypoglossal nerve to manage obstructive sleep apnea by maintaining airway patency.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 75
Sex:All
124 Participants Needed
Sivopixant + Acetazolamide + SASS-001 for Sleep Apnea
Cincinnati, OhioThe primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Heart Failure, Stroke, COPD, Others
Must Not Be Taking:Opioids, Digoxin, Lithium, Others
60 Participants Needed
Portable Oxygen Concentrator for Obstructive Sleep Apnea
Cincinnati, OhioConducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.
The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Current CPAP Use, Oxygen Saturation < 90%, Others
10 Participants Needed
CPAP for Sleep Apnea After Stroke
Cincinnati, OhioThe purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Mechanical Ventilation, Pneumothorax, Others
3062 Participants Needed
AD109 for Obstructive Sleep Apnea
Louisville, KentuckyThe combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18+
Sex:All
1280 Participants Needed
Inspire Therapy for Obstructive Sleep Apnea
Cincinnati, OhioThe purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Sex:All
127 Participants Needed
AD109 for Obstructive Sleep Apnea
Cincinnati, OhioThis is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
740 Participants Needed
Orforglipron for Obstructive Sleep Apnea
Cincinnati, OhioStudy GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Upper Airway Surgery, Others
600 Participants Needed
Personalized Surgery for Sleep Apnea in Down Syndrome
Cincinnati, OhioThe overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT.
It is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous Tonsillectomy, Bleeding Disorders, Cardiopulmonary Comorbidity, Others
303 Participants Needed
CFD Simulations for Pediatric Sleep Apnea
Cincinnati, OhioTo create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA). The first line of treatment for children with OSA is to remove their tonsils and adenoids; however, these surgeries do not always cure the patient. Another treatment, continuous positive airway pressure (CPAP) is only tolerated by 50% of children. Therefore, many children undergo surgical interventions aimed at soft tissue structures surrounding the airway, such as tonsils, tongue, and soft palate, and/or the bony structures of the face. However, the success rates of these surgeries is surprisingly low. Therefore, there a need for a tool to improve the efficacy and predict which surgical option is going to benefit each individual patient most effectively. Computational fluid dynamics (CFD) simulations of respiratory airflow in the upper airways can provide this predictive tool, allowing the effects of various surgical options to be compared virtually and the option most likely to improve the patient's condition to be chosen. Previous CFD simulations have been unable to provide information about OSA as they were based on rigid geometries, or did not include neuromuscular motion, a key component in OSA. This project uses real-time magnetic resonance imaging (MRI) to provide the anatomy and motion of the airway to the CFD simulation, meaning that the exact in vivo motion is modeled for the first time. Furthermore, since the modeling is based on MRI, a modality which does not use ionizing radiation, it is suitable for longitudinal assessment of patients before and after surgical procedures. In vivo validation of these models will be achieved for the first time through comparison of CFD-based airflow velocity fields with those generated by phase-contrast MRI of inhaled hyperpolarized 129Xe gas. This research is based on data obtained from sleep MRIs achieved with the subject under sedation. While sedating the patient post-operatively is slightly more than minimal risk, the potential benefits to each patient outweigh this risk. As 58% of patients have persistent OSA postsurgery and the average trajectory of OSA severity is an increase over time, post-operative imaging and modeling can benefit the patient by identifying the changes to the airway made during surgery and which anatomy should be targeted in future treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:3 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Adequately Treated With CPAP, Braces, Others
120 Participants Needed
IHL-42X for Obstructive Sleep Apnea
Cincinnati, OhioThe goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure.
Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients.
The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III.
Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Obesity, Sedative Use, Severe Depression, Others
Must Not Be Taking:Sedative-hypnotics, Stimulants
560 Participants Needed
AD109 for Obstructive Sleep Apnea
Cincinnati, OhioThis trial is testing a specific combination of medications called AD109 to see if it helps people with Obstructive Sleep Apnea. The goal is to find out if AD109 can keep airways open during sleep. The study will last for several months and compare the effects of AD109.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
660 Participants Needed
Hypoglossal Nerve Stimulation for Down Syndrome
Cincinnati, OhioThis study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:High BMI, Autism, Others
Must Not Be Taking:Muscle Relaxants, NSAIDs
57 Participants Needed
Oxygen Therapy for Down Syndrome with Sleep Apnea
Cincinnati, OhioThe purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:5 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:CPAP Use, Congenital Heart Disease, Others
Must Not Be Taking:Pulmonary Vasodilators
230 Participants Needed
Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Leukemia, Severe Heart Disease, Others
86 Participants Needed
Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
Louisville, KentuckyMulti-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Sex:All
150 Participants Needed
Mandibular Advancement Device for Nocturia
Lexington, KentuckyThis trial tests if a mouthpiece that keeps the lower jaw forward can help people who frequently urinate at night by improving their sleep. These devices have been used to help with breathing issues during sleep.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Sleep Disorders, Urological Disease, Pregnancy, Heart Failure, Diabetes, Others
Must Not Be Taking:Diuretics
36 Participants Needed
Transvenous Nerve Stimulation for Sleep Apnea
Columbus, OhioThe purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, BMI > 40, Others
Must Not Be Taking:Muscle Relaxants
30 Participants Needed
Negative Pressure Device for Sleep Apnea
Columbus, OhioThis trial tests the aerSleep® II device, which helps people with sleep apnea breathe better at night. It targets adults who can't use the usual CPAP therapy. The device works by keeping the airway open during sleep.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
900 Participants Needed
Diagnostic Method for Obstructive Sleep Apnea
Columbus, OhioThis 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
300 Participants Needed
CPAP for Sleep Apnea in Pregnancy
Columbus, OhioA randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Asthma, Chronic Renal Disease, Others
Must Not Be Taking:Sleeping Pills, Opiates
1500 Participants Needed
CPAP + Lifestyle Intervention for Prediabetes
Chicago, IllinoisDespite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Formal Weight Loss, Others
174 Participants Needed
CPAP + Niacin for Sleep Apnea and Prediabetes
Chicago, IllinoisThis trial tests how different treatments for sleep apnea affect blood sugar levels in patients with prediabetes. The goal is to see how these methods influence blood sugar control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:20 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Severe Hypertension, Bleeding Disorders, Others
Must Not Be Taking:Confounding Medications
300 Participants Needed
Sleep-Promoting Interventions for Stroke Rehabilitation
Chicago, IllinoisThe SIESTA-Rehabilitation protocol combines two sleep-promoting interventions, (1) empowering nurses to reduce unnecessary disruptions and (2) a systematic protocol to screen, diagnose, and treat sleep-disordered breathing, to determine its impact on relevant sleep and rehabilitation outcomes in the acute inpatient stroke rehabilitation setting compared to the standard of care. Our primary outcome is change in Quality Indicator (QI) score, a measure that has replaced the Functional Independence Measure (FIM) in the inpatient setting at the Shirley Ryan AbilityLab, between admission and discharge.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Serious Cardiac, Neurological Degenerative, Others
400 Participants Needed
Watermelon for High Blood Pressure
Chicago, Illinois1. Primary outcome: To evaluate the dose response effects of watermelon flesh in regulating Blood Pressure (BP) in individuals with pre-hypertension.
2. Secondary outcomes: To study the dose-response effects of watermelon flesh intake on cardio-metabolic risk factors including plasma metabolic markers, lipid profile and nitrate/nitrite levels in individuals with pre-hypertension.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:25 - 65
Sex:All
36 Participants Needed
Dronabinol for Sleep Apnea
Chicago, IllinoisThis is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Sex:All
120 Participants Needed
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Frequently Asked Questions
How much do Apnea clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Apnea clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Apnea trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Apnea is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Apnea medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Apnea clinical trials ?
Most recently, we added Nerve Stimulation for Obstructive Sleep Apnea, Acetazolamide for Central Sleep Apnea in Opioid Users and Dronabinol for Sleep Apnea to the Power online platform.