2025 Clinical Trials Advancing Novel Sleep Apnea Treatments and Participant Eligibility in the United States

Exploring new horizons in sleep apnea therapies: drugs and devices

Obstructive sleep apnea, characterized by repeated airway collapse during sleep, affects many people and is associated with cardiovascular, metabolic, and neurocognitive risks. CPAP remains a widely used standard of care, but research in 2025 is expanding toward pharmacological and refined device approaches that may offer alternative or complementary options.

Breakthroughs in oral medications

• Several investigational oral agents that aim to improve upper airway neuromuscular control are being evaluated in late-stage clinical trials in the United States. These agents use pharmacologic mechanisms intended to increase muscle tone or stability of the upper airway during sleep. Trial designs, endpoints, and timelines vary by sponsor; readers should consult trial registries for up-to-date details.
• Separately, weight-loss medications — including GLP-1 receptor agonists and dual agonists under investigation for metabolic indications — have been associated with reductions in body weight and, in some studies, improvements in OSA severity that appear related to weight loss. These drugs are not FDA-approved specifically for OSA; any potential use for sleep apnea would depend on further evidence and regulatory decisions.

Progress in device-based solutions

• Next-generation positive airway pressure (PAP) systems and mask designs are being developed to improve comfort, portability, and adherence.
• Implantable upper airway neurostimulation systems are available in select settings and continue to be refined; they remain options for carefully selected patients and are the subject of ongoing research.
• Combination strategies that pair pharmacologic agents with device therapies are under study to determine whether multimodal approaches improve outcomes more than single interventions.

These lines of research reflect a move toward more personalized treatment, targeting both the anatomy and neuromuscular contributors to OSA.

Typical eligibility criteria for sleep apnea clinical research

Eligibility varies by study, but common inclusion criteria for many U.S.-based OSA trials in 2025 include:

• Adults (many studies enroll ages 18–65, though some extend upper age limits to 70–85 depending on trial goals).
• A confirmed OSA diagnosis using standardized sleep testing (for example, polysomnography or validated home sleep apnea testing), with severity thresholds specified by the protocol.
• Stable or controlled comorbid conditions; patients with severe uncontrolled illness are frequently excluded for safety reasons.
• Ability and willingness to attend scheduled visits and comply with study procedures.
• Not currently enrolled in conflicting interventional clinical trials.

Study-specific criteria can be more restrictive (for example, excluding certain medications, prior surgeries, or specific BMI ranges), so prospective participants should review each trial’s eligibility requirements.

Diagnostic and monitoring services provided during trials

Many sleep apnea studies provide participants with study-related diagnostics and monitoring at no cost, which can include:

• Baseline and follow-up sleep studies (in-lab or home-based) using respiratory and neurological monitoring equipment.
• Routine safety labs and medical assessments.
• Specialist oversight by sleep medicine clinicians and research staff throughout the trial.

These services support participant safety and high-quality data collection; the exact tests and frequency depend on the protocol.

Participant recruitment for sleep apnea studies

Recruitment in the United States commonly occurs through academic medical centers, specialty sleep clinics, and research networks. University-affiliated centers (including multiple University of California campuses) and large health systems frequently list ongoing trials. People can find opportunities via:

• Institutional clinical trial registries and research pages.
• Certified sleep disorder clinics and local specialists.
• Public clinical trial databases (for example, ClinicalTrials.gov).
• Referrals from primary care or specialty providers.

Investigators increasingly try to recruit diverse populations to improve generalizability.

Key themes: combination treatments and neuromuscular targets

Current research highlights two major contributors to OSA:

1. Anatomical narrowing (frequently associated with excess upper body and neck adiposity).
2. Neuromuscular dysfunction (reduced upper airway muscle activity during sleep).

Future effective strategies may combine behavioral, metabolic, pharmacologic, device-based, or surgical approaches tailored to an individual’s dominant mechanisms.

Considerations for those participating in trials

• Many trials cover study-related medical care, diagnostics, and the investigational treatment. Compensation for time and travel is often provided to offset participant expenses; amounts and policies vary and are not intended to unduly influence participation.
• Participation is voluntary, and informed consent procedures explain risks, benefits, and alternatives.
• Trials operate under institutional review board (IRB) oversight and applicable regulatory standards.

The future of sleep apnea management in 2025 and beyond

Results from ongoing trials may broaden treatment choices for OSA by:

• Clarifying whether oral medications that target neuromuscular control can provide clinically meaningful benefits for selected patients.
• Defining the role of metabolic therapies (via weight loss) in improving OSA outcomes.
• Improving device comfort and adherence through design advances.
• Informing multimodal, personalized treatment plans that address both anatomical and neuromuscular contributors.

Any changes to clinical practice will depend on confirmatory trial evidence, regulatory review, and clinical guideline updates.

This article is intended for informational purposes and does not replace professional medical advice. Individuals should consult healthcare providers for personalized diagnosis and treatment decisions.

Sources

• Clinical Trials on Sleep Disorders, University of California Health System: https://clinicaltrials.ucbraid.org/sleep-disorder
• Healio Pulmonology: Q&A with OSA Experts on New Era for Care in 2025: https://www.healio.com/news/pulmonology/20250117/qa-dawn-of-a-new-era-for-osa-care-moving-into-2025
• Everyday Mosaic: Sleep Apnea Trials: New Frontiers in Treatment: https://everyday-mosaic.com/en/articles/sleep-apnea-trials-new-frontiers-in-treatment

Clinical trial prices, availability, and eligibility criteria differ by location and study. Interested people should consult trial sponsors or healthcare providers for current information.