← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Study 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
Select...
I have moderate-to-severe sleep apnea.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,626 Previous Clinical Trials
11,473,589 Total Patients Enrolled

Media Library

Atomoxetine (Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05350215 — Phase 1 & 2
Obstructive Sleep Apnea Research Study Groups: Placebo oral capsules, Atomoxetine and DAW2020 oral capsules
Obstructive Sleep Apnea Clinical Trial 2023: Atomoxetine Highlights & Side Effects. Trial Name: NCT05350215 — Phase 1 & 2
Atomoxetine (Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350215 — Phase 1 & 2
~6 spots leftby Jun 2025