What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and pharmacological treatments. CPAP can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Oral appliances may lead to jaw discomfort, excessive salivation, and dental issues. Pharmacological treatments, including those similar to the fixed-dose combination in the AD109 trial, can have side effects like dizziness, headache, gastrointestinal disturbances, and potential interactions with other medications. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The primary FDA-approved treatment for Obstructive Sleep Apnea (OSA) is Continuous Positive Airway Pressure (CPAP) therapy, which is widely recognized for its effectiveness. Pharmacotherapy has not shown significant efficacy in treating OSA broadly, though specific drugs like acetazolamide and zonisamide have emerging evidence supporting their use in particular scenarios, such as high-altitude travel and weight loss, respectively. The AD109 trial is investigating a fixed-dose combination for OSA, which represents a novel approach compared to the existing treatments.

What other types of research exist?

Promising, novel alternatives to AD109 for Obstructive Sleep Apnea patients include: 1) A novel implantable device that has shown preliminary feasibility and safety in a multicenter study, and 2) Upper airway surgical interventions, which remain a viable option for OSA treatment. Patients should discuss these options with their healthcare provider to determine the best course of action.

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AD109 for Obstructive Sleep Apnea

Verified Trial

Phase 3

Recruiting

Research Sponsored by Apnimed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age at the time of informed consent

PAP intolerance or current PAP refusal

Must not have

Narcolepsy, restless leg syndrome, REM sleep behavior disorder

Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a specific combination of medications called AD109 to see if it helps people with Obstructive Sleep Apnea. The goal is to find out if AD109 can keep airways open during sleep. The study will last for several months and compare the effects of AD109.

Who is the study for?

This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI >5, don't respond well to PAP therapy, and feel very tired. They should not be too overweight (BMI limits apply differently for men and women). People with certain sleep disorders, severe heart issues, or significant neurological diseases cannot join.

What is being tested?

The study tests AD109 against a placebo in people with OSA. It's a year-long test where participants are randomly chosen to receive either the real drug or a fake one without knowing which they're getting. The goal is to see if AD109 helps better than the placebo.

What are the potential side effects?

Since this summary doesn't provide specific side effects of AD109, generally speaking, possible side effects could include typical drug reactions like nausea, headaches, dizziness or allergic responses. However, details would depend on the nature of AD109.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I cannot tolerate or refuse to use a CPAP machine.

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My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

Exclusion Criteria

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

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I have been diagnosed with narcolepsy, restless leg syndrome, or REM sleep behavior disorder.

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I have trouble falling or staying asleep, or I've used sleep medication in the last month.

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I have a craniofacial syndrome or very large tonsils.

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I do not have conditions like muscular dystrophy, epilepsy, or Alzheimer's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy of AD109 on airway obstruction in mild to severe OSA

Side effects data

From 2021 Phase 2 trial • 60 Patients • NCT04580394

Gastroesophageal reflux disease

Cardiac Arrythmia

Headache

Seizure

Atrial Fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

A: AD109

B: Atomoxetine 75 mg + Placebo

C: R-oxybutynin 2.5 mg + Placebo

D:Placebo + Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AD109Experimental Treatment1 Intervention

AD109

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AD109

2021

Completed Phase 2

~360

0 / 7Eligibility 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), oral appliances, and pharmacologic agents. CPAP works by providing a steady stream of air through a mask to keep the airway open during sleep, preventing apneas and hypopneas. Oral appliances reposition the jaw or tongue to maintain airway patency. Pharmacologic treatments, such as those being studied in the AD109 trial, often aim to reduce upper airway collapsibility or stimulate respiratory drive. For example, AD109 is a fixed-dose combination that may include agents to enhance airway muscle tone and improve breathing stability. These mechanisms are crucial for OSA patients as they directly address the airway obstruction that characterizes the condition, thereby improving sleep quality, reducing daytime sleepiness, and lowering the risk of associated cardiovascular and metabolic complications.

Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.Effects of opioid, hypnotic and sedating medications on sleep-disordered breathing in adults with obstructive sleep apnoea.Treatment of Obstructive Sleep Apnea. Prospects for Personalized Combined Modality Therapy.