A Novel Pharmacological Therapy for Obstructive Sleep Apnea

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Apnea

In brief

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?

Key facts

Study ID

NCT03919955

Run by

Brigham and Women's Hospital

People needed

117

Starts

2019-09-03

Expected to finish

2023-09-07

Last updated by the study team

2026-07-02

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 21-70 years
• Diagnosed OSA or clinically-suspected OSA
• Not using CPAP (>1 month).

You may not qualify if…

• 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 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
• Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 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<24).
• history of attempted suicide or suicidal ideation within one year prior to screening
• clinically significant constipation, gastric retention
• pre-existing seizure disorders
• clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2)
• clinically-significant liver disorders
• clinically-significant cardiovascular conditions
• severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline)
• cardiomyopathy (LVEF<50%) or heart failure

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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