Phase 2
Completed N=58
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03919955 ↗Enrolled (actual)
58
Serious AEs
0.9%
Results posted
Dec 2025
Primary outcomePrimary: Apnea-hypopnea Index [AHI] — -11.8; -2.3 events/hr; % change from baseline
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?
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 | — |
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. Informational only — not medical advice.