Phase 2
N=58
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03919955 ↗Enrolled (actual)
58
Serious AEs
0.9%
Results posted
Dec 2025
Primary outcome: Primary: Apnea-hypopnea Index [AHI] — -11.8; -2.3 events/hr; % change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atomoxetine (Drug); Oxybutynin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index [AHI] |
-11.8; -2.3 | — |
| SECONDARY Hypoxic Burden |
-15.0; -8.7 | — |
| SECONDARY Arousal Index |
-0.3; -3.7 | — |
| SECONDARY Epworth Sleepiness Scale |
0; -1 | — |
| SECONDARY Functional Outcomes of Sleep Questionnaire, Short Form |
0.33; 0 | — |
| SECONDARY Sleep Apnea Quality of Life Index, Short Form |
0.3; 0.4 | — |
Summary
A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study will answer the following questions: Does ongoing, repeated-dose administration of atomoxetine-plus-oxybutynin (referred to as "AtoOxy") improve OSA severity, and do patients exhibit signs of symptomatic relief? Most importantly, which phenotypic subgroup of patients preferentially benefit from this intervention?
Eligibility Criteria
Inclusion criteria
- Ages 21-70 years
- Diagnosed OSA or clinically-suspected OSA
- Not using CPAP (>1 month).
Exclusion criteria
- Any uncontrolled medical condition
- Current use of the medications under investigation
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines).
- Current use of SNRIs/SSRIs or anticholinergic medications.
- Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
- Respiratory disorders other than sleep disordered breathing:
chronic hypoventilation/hypoxemia (awake SaO2 10/hr), narcolepsy, or parasomnias.
- Contraindications for atomoxetine and oxybutynin, including:
- hypersensitivity to study drugs (angioedema or urticaria)
- pheochromocytoma
- use of monoamine oxidase inhibitors
- benign prostatic hypertrophy, urinary retention
- untreated narrow angle glaucoma
- bipolar disorder, mania, psychosis
- history of major depressive disorder (age 180 mmHg or DBP>110 mmHg measured at baseline)
- cardiomyopathy (LVEF<50%) or heart failure
- advanced atherosclerosis
- history of cerebrovascular events
- history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
- other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
- myasthenia gravis
- pregnancy/breast-feeding
- Allergy to lidocaine (Aim 2 only)
- Claustrophobia
- Pregnancy or nursing
Data sourced from ClinicalTrials.gov (NCT03919955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.