What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) that modulate arousal threshold and upper airway muscle recruitment, such as atomoxetine and oxybutynin, can have side effects including dry mouth, constipation, urinary retention, and increased heart rate. Continuous Positive Airway Pressure (CPAP) therapy, another common treatment, may cause nasal congestion, dry mouth, and skin irritation. Surgical interventions, while effective for some, carry risks of infection, pain, and complications from anesthesia. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for Obstructive Sleep Apnea (OSA) include positive airway pressure (PAP) therapies, such as CPAP and BiPAP, which are the most common and effective treatments. Additionally, oral appliances like mandibular advancement devices are approved for mild to moderate OSA. Pharmacologic treatments like modafinil and armodafinil are approved for managing residual excessive daytime sleepiness in OSA patients. While these treatments do not directly modulate arousal threshold or upper airway muscle recruitment, they address the symptoms and consequences of OSA. Investigational treatments, such as the carbonic anhydrase inhibitor sulthiame, have shown promise in reducing apnea-hypopnea index (AHI) but are not yet widely approved.

What other types of research exist?

Promising novel alternatives to DAW2020 for treating Obstructive Sleep Apnea in 2024 include: 1) Non-invasive electrical stimulation devices like Apone-Stim 400 Muscle Stimulator and eXciteOSA, which have shown effectiveness in reducing snoring and potentially improving OSA. 2) Hypoglossal cranial nerve upper airway stimulation (UAS), which has demonstrated positive outcomes in clinical trials for moderate to severe OSA. 3) Oral appliances, which are effective in managing OSA and have cardiovascular benefits.

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DAW2020 for Obstructive Sleep Apnea (SedOSA Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-to-severe OSA (AHI ≥ 15 events/hr)

Be older than 18 years old

Must not have

Hypokalemia, hypomagnesemia, uncontrolled thyroid disease

Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Summary

This trial tests DAW2020, a medication taken at bedtime, on patients with obstructive sleep apnea who wake up too early during breathing interruptions. The medication helps them stay asleep longer, allowing their throat muscles to open up their airways naturally.

Who is the study for?

This trial is for adults with moderate-to-severe Obstructive Sleep Apnea (OSA), having at least 15 events per hour. It's not suitable for those with other sleep disorders, on certain medications affecting respiration or QTc interval, allergic to the study drug, major organ diseases, severe claustrophobia, or unstable medical conditions.

What is being tested?

The trial tests if DAW2020 oral capsules taken before sleep can improve OSA by preventing premature awakenings during obstructive events. Participants will be randomly given either DAW2020 or a placebo capsule to compare effects on OSA severity and traits.

What are the potential side effects?

Potential side effects of DAW2020 may include allergic reactions like angioedema or urticaria for those sensitive to the drug. Other risks might relate to interactions with medications that affect breathing or heart rhythm but specific side effects are not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate-to-severe sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have low potassium, low magnesium, or uncontrolled thyroid issues.

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I am not taking medications that affect my breathing.

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I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.

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I have no known allergies or adverse reactions to DAW2020.

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I have a sleep or breathing disorder that is not obstructive sleep apnea.

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I am taking medication that affects my heart's electrical cycle.

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I do not have major neurological disorders, heart failure, or other unstable conditions.

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I have severe claustrophobia.

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I do not have any major organ disease that would prevent me from undergoing certain medical tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of DAW2020 on arousal threshold (%eupnea)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DAW2020Active Control1 Intervention

DAW2020 capsule 4 hours before sleep

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsule 4 hours before sleep

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and pharmacotherapy. CPAP works by providing a steady stream of air through a mask to keep the airway open during sleep. Oral appliances reposition the jaw or tongue to prevent airway obstruction. Pharmacotherapy, such as the combination of noradrenergic agents and antimuscarinic drugs, targets the upper airway motor circuitry to enhance muscle tone and reduce airway collapsibility. These treatments are crucial for OSA patients as they help maintain airway patency, reduce apneic events, and improve sleep quality, thereby mitigating the associated health risks like cardiovascular disease and daytime sleepiness.

Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.The noradrenergic agent reboxetine plus the antimuscarinic hyoscine butylbromide reduces sleep apnoea severity: a double-blind, placebo-controlled, randomised crossover trial.A resource of potential drug targets and strategic decision-making for obstructive sleep apnoea pharmacotherapy.