What is the mechanism of action of this treatment?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), which maintains airway patency by providing a constant stream of air, and oral appliances that reposition the jaw to keep the airway open. Pharmacological treatments, such as the combination of Atomoxetine and Oxybutynin, work by increasing upper airway muscle activity and reducing muscle relaxation during sleep. Atomoxetine, a norepinephrine reuptake inhibitor, enhances muscle tone, while Oxybutynin, an antimuscarinic agent, reduces muscle relaxation. These mechanisms are crucial for OSA patients as they directly target the airway collapse that characterizes the disorder, potentially offering an alternative for those who cannot tolerate CPAP or other mechanical interventions.

What side effects are associated with this type of intervention?

Common pharmacologic treatments for Obstructive Sleep Apnea (OSA) include medications like atomoxetine and oxybutynin, which have been shown to reduce OSA severity by increasing upper airway muscle activity. Known side effects of these medications can include dry mouth, urinary retention, and potential cognitive effects due to their anticholinergic properties. Other pharmacologic agents, such as theophylline and acetazolamide, may cause side effects like gastrointestinal disturbances, dizziness, and electrolyte imbalances. Overall, while these medications can be effective, they often come with a range of side effects that need to be carefully managed.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA), primarily focusing on devices like Continuous Positive Airway Pressure (CPAP) machines and oral appliances. Pharmacological treatments are less common, but recent research has explored the use of medications like Atomoxetine and Oxybutynin, which target pharyngeal muscle activity to improve OSA symptoms. These drugs are being studied for their potential to enhance muscle tone in the airway, thereby reducing the severity of OSA. While specific FDA approvals for these medications in the context of OSA are not detailed, their use represents a novel approach in the ongoing effort to manage this complex condition.

What other types of research exist?

Promising novel alternatives to Atomoxetine and Oxybutynin for Obstructive Sleep Apnea patients include nasal expiratory positive airway pressure (PAP), oral negative pressure, upper airway muscle stimulation, and bariatric surgery. Additionally, the combination of reboxetine and hyoscine butylbromide has shown efficacy in reducing OSA severity and could be considered as a viable treatment option.

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Atomoxetine + Oxybutynin for Obstructive Sleep Apnea

Phase 1 & 2

Waitlist Available

Led By Scott A Sands, PhD

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

Diagnosed OSA (AHI≥15 events/h reported in PSG performed within one year) or Suspected OSA (snoring, sleepiness, witness apneas, other clinical symptoms)

Be older than 18 years old

Must not have

Any uncontrolled medical condition

Current use of the medications under investigation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Awards & highlights

Summary

This trial is testing a combination of atomoxetine and oxybutynin to help people with obstructive sleep apnea (OSA). Previous studies have shown that the combination of these drugs can significantly reduce the severity of OSA by increasing upper airway muscle activity during sleep. The drugs may work by increasing the activity of throat muscles, making it easier to breathe during sleep.

Who is the study for?

This trial is for adults with diagnosed or suspected obstructive sleep apnea (OSA) who are not currently using CPAP therapy. People with neuromuscular diseases, heart failure, other major medical conditions, or those taking certain medications that affect respiration or have contraindications to the study drugs cannot participate.

What is being tested?

The study tests how well Atomoxetine (80 mg), Oxybutynin (5 mg), and their combination improve muscle control in the throat for OSA patients compared to a placebo. It aims to understand if these drugs can be an effective treatment by studying their individual and combined effects.

What are the potential side effects?

Possible side effects of Atomoxetine may include dry mouth, trouble sleeping, decreased appetite, increased blood pressure and heart rate. Oxybutynin might cause dry mouth, constipation, dizziness and blurred vision. The combination could potentially amplify these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with severe sleep apnea or suspect I have it due to symptoms like snoring.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled medical conditions.

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I am currently taking the medication being studied.

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Criterion: You cannot participate if you have specific health conditions, such as certain allergies, heart problems, or psychological issues.

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I am currently taking SNRIs/SSRIs or anticholinergic medications.

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I have a lung condition that is not sleep-related and causes low oxygen levels.

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I have a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.

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I am not taking medications that affect my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Genioglossus Activity

Tensor Palatini Activity

Ventilation

Secondary study objectives

Muscle Effectiveness (V-Drive slope)

Peak genioglossus responsiveness (GG-Drive slope)

Peak genioglossus, baseline activation, i.e. at eupneic ventilatory drive (GGpassive)

+3 more

Other study objectives

Arousal Threshold

Loop Gain

Tonic genioglossus activity, unadjusted for ventilatory drive (GGtonic,min)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Atomoxetine-plus-Oxybutynin (AtoOxy)Experimental Treatment1 Intervention

80mg atomoxetine and 5mg of oxybutynin administered to participant, 30 min prior to bed.

Group II: AtomoxetineActive Control1 Intervention

80mg atomoxetine and placebo administered to participant, 30 min prior to bed.

Group III: PlaceboPlacebo Group1 Intervention

Placebo plus placebo administered to participant, 30mins prior to bed

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), which maintains airway patency by providing a constant stream of air, and oral appliances that reposition the jaw to keep the airway open. Pharmacological treatments, such as the combination of Atomoxetine and Oxybutynin, work by increasing upper airway muscle activity and reducing muscle relaxation during sleep. Atomoxetine, a norepinephrine reuptake inhibitor, enhances muscle tone, while Oxybutynin, an antimuscarinic agent, reduces muscle relaxation. These mechanisms are crucial for OSA patients as they directly target the airway collapse that characterizes the disorder, potentially offering an alternative for those who cannot tolerate CPAP or other mechanical interventions.

The norepinephrine reuptake inhibitor reboxetine alone reduces obstructive sleep apnea severity: a double blind, placebo controlled, randomized, cross-over trial.Different antimuscarinics when combined with atomoxetine have differential effects on obstructive sleep apnea severity.Targeting Endotypic Traits with Medications for the Pharmacological Treatment of Obstructive Sleep Apnea. A Review of the Current Literature.