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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
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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,812 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to join this clinical research at the moment?

"Affirmative. According to the details found on clinicaltrials.gov, recruitment for this study is currently underway with 18 patients needed at one location. It was initially posted in June of 2022 and recently modified in July."

Answered by AI

Is participation in this medical study open to me?

"This research trial is recruiting 18 individuals suffering from obstructive sleep apnea between the ages of 21 and 70. More specifically, participants must present with moderate-to-severe OSA (AHI ≥ 15 events/hr)."

Answered by AI

What is the participant capacity for this research project?

"Affirmative. The information hosted on clinicaltrials.gov implies that this examination is currently looking for participants; it was initially publicized on June 1st 2022 and most recently edited a month later, the 25th of July. This experiment necessitates 18 individuals to be recruited from one medical site."

Answered by AI

Is the eligibility criteria for this clinical trial inclusive of geriatric patients?

"To participate in this medical study, participants must be between 21 and 70 years old. There are 37 studies catered towards those younger than 18 while 193 trials focus on the elderly population (aged 65+)."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Atomoxetine and DAW2022 on OSA Severity
David Andrew Wellman 2022. "Atomoxetine and DAW2022 on OSA Severity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05350215.
~1 spots leftby Jun 2024
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