What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include hypnotics and norepinephrine reuptake inhibitors. Hypnotics like DAW2020, which aim to prolong total sleep time, can have side effects such as daytime drowsiness, dependency, and potential worsening of sleep apnea symptoms. Atomoxetine, a norepinephrine reuptake inhibitor, is generally used to reduce OSA severity but may cause side effects like dry mouth, insomnia, and increased heart rate. Combining these treatments can be effective but requires careful monitoring for adverse effects.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments for Obstructive Sleep Apnea (OSA) that directly match the combination of a hypnotic to prolong total sleep time and a norepinephrine reuptake inhibitor to reduce OSA severity, as studied with DAW2020 and Atomoxetine. However, treatments like CPAP (Continuous Positive Airway Pressure) and oral appliances are commonly used. Additionally, medications such as Modafinil and Armodafinil, which are wake-promoting agents, have been approved to manage residual sleepiness in OSA patients. These treatments focus on managing symptoms rather than directly addressing the arousal threshold or sleep architecture as the trial drugs aim to do.

What other types of research exist?

Promising alternatives for OSA treatment in 2024 include Modafinil/Armodafinil, which are wakefulness-promoting agents effective in reducing excessive daytime sleepiness in OSA patients, and Doxepin, a low-dose tricyclic antidepressant with sedative properties that can help with sleep maintenance. These alternatives offer potential benefits in managing both sleep quality and OSA symptoms.

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Norepinephrine Reuptake Inhibitor

Atomoxetine + DAW2022 for Obstructive Sleep Apnea

Phase 1 & 2

Recruiting

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

Participants with major organ system disease that would preclude undergoing the physiological measurements

Use of medications that lengthen QTc interval

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

Summary

This trial suggests that DAW2020 could be a viable treatment option for OSA patients when used in conjunction with atomoxetine.

Who is the study for?

This trial is for adults with moderate-to-severe obstructive sleep apnea (OSA), which means they have at least 15 breathing interruptions per hour of sleep. People can't join if they have major organ diseases, use certain medications that affect heart rhythm or respiration, suffer from severe claustrophobia, other sleep disorders like narcolepsy, are allergic to the study drugs, or have unstable medical conditions.Check my eligibility

What is being tested?

The trial is testing whether Atomoxetine combined with a new hypnotic drug called DAW2022 can reduce the severity of OSA without causing too much drowsiness. Participants will either receive this combination or a placebo in a controlled setting to compare effects.See study design

What are the potential side effects?

Atomoxetine may cause dry mouth, trouble sleeping, nausea and increased blood pressure. The new drug DAW2022 could potentially lead to similar side effects as oxybutynin such as drowsiness but aims to be safer with fewer anticholinergic effects.

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 any major organ disease that would prevent me from undergoing certain medical tests.

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I am not taking medications that affect my heart's electrical cycle.

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

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I am not allergic or unable to take DAW2020 due to health reasons.

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

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

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I am not taking medications that affect my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of atomoxetine and DAW2020 on OSA severity

Secondary outcome measures

Effect of atomoxetine and DAW2020 on arousal index

Atomoxetine

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Atomoxetine and DAW2020 oral capsulesActive Control1 Intervention

DAW2020 34 mg 4 h before sleep, single night administration for a week. Simultaneous administration of atomoxetine 40 mg for 3 days 30 min before sleep, 80 mg for the following 4 days, 30 min before sleep

Group II: Placebo oral capsulesPlacebo Group1 Intervention

Placebo (2 pills) before sleep for a week

0 / 8Eligibility 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

The most common treatments for Obstructive Sleep Apnea (OSA) include continuous positive airway pressure (CPAP), oral appliances, and pharmacologic agents. Hypnotics, such as DAW2020, work by prolonging total sleep time, which can help maintain sleep continuity and reduce arousals. Atomoxetine, a norepinephrine reuptake inhibitor, reduces OSA severity by increasing upper airway muscle tone and reducing airway collapsibility. These mechanisms are crucial for OSA patients as they address the core issues of airway obstruction and sleep fragmentation, potentially improving overall sleep quality and reducing the health risks associated with OSA.

Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial.