Effects of the Combination of Pimavanserin and Atomoxetine on OSA Severity: A Randomized Crossover Trial.
Ludovico Messineo, Madison Preuss, Ali Azarbarzin...
https://pubmed.ncbi.nlm.nih.gov/40158847Actively Recruiting
Phase 1
Phase 2
Age: 21Years - 70Years
All Genders
ID05350215
Effect of Atomoxetine and DAW2022 on Obstructive Sleep Apnea Severity
Led by Brigham and Women's Hospital · Updated on 2026-03-03
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effects of atomoxetine combined with DAW2020 on the severity of obstructive sleep apnea (OSA), a common condition with serious health impacts and limited treatment options. Previous studies showed that atomoxetine and oxybutynin could reduce OSA severity but also lowered the arousal threshold, which is important in OSA. DAW2020, a hypnotic that increased total sleep time in prior trials, may be a better option to pair with atomoxetine for this purpose. Participants will undergo two overnight sleep studies: one with the study drugs and one with placebo, separated by a one-month washout period. Before each sleep study, they will have a physical exam and a pregnancy test if applicable. The drug regimen includes a 3-day run-in of atomoxetine 40 mg, then 80 mg for the following days, taken 30 minutes before sleep. DAW2020 34 mg will be given for one week, 4 hours before sleep. Sleep and respiratory variables will be monitored for at least four hours each night using full polysomnography. During the study, participants will be observed overnight in a sleep lab with detailed monitoring of sleep, breathing, and physiological variables. Researchers will measure the effect of the drugs on OSA severity, arousal index, and oxygen levels during sleep. The study uses a randomized, quadruple-blind design with placebo comparison. The total participation includes two sleep studies with a month apart, and safety and response will be closely assessed throughout.
CONDITIONS
Brief Title
Atomoxetine and DAW2022 on OSA Severity
Who Can Participate
Age: 21Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Moderate-to-severe obstructive sleep apnea with apnea-hypopnea index of 15 or more events per hour
- Adults aged 21 to 70 years
You will not qualify if you...
- Major organ system disease that prevents physiological measurements
- Use of medications that stimulate or depress breathing, including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, or 4-hydroxybutanoic acid
- Use of SNRIs or SSRIs
- Neuromuscular disease or major neurological disorders
- Heart failure or other unstable major medical conditions
- Sleep disorders other than obstructive sleep apnea, including periodic limb movements, narcolepsy, or parasomnias
- Hypersensitivity to study drugs such as angioedema or urticaria
- Contraindications to DAW2020
- Use of medications that lengthen QTc interval
- Low potassium or magnesium levels, uncontrolled thyroid disease
- Severe claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 3 days
Participants take atomoxetine 40 mg nightly for 3 days before starting the treatment phase.
Daily medication intake at home
Treatment
Duration - 1 week per treatment period, with a 1-month washout between periods
Participants receive atomoxetine and DAW2020 or placebo for one week in a crossover design with a one-month washout between treatments. During treatment weeks, participants take medication daily and complete two overnight sleep studies: one drug night and one placebo night.
2 overnight sleep study visits (in-person)
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02135
Actively Recruiting
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Research Team
L
Ludovico Messineo, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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