What side effects are associated with this type of intervention?

Common treatments for sleep apnea include Positive Airway Pressure (PAP) therapy and various pharmacological agents. PAP therapy, such as CPAP (Continuous Positive Airway Pressure), can cause side effects like nasal congestion, dry mouth, skin irritation from the mask, and discomfort. Pharmacological agents, which are less commonly used as primary treatments, may include drugs like theophylline, acetazolamide, and dronabinol. These can have side effects such as gastrointestinal disturbances, dizziness, visual disturbances, and potential impacts on mental wakefulness. Combination therapy involving PAP and pharmacological agents aims to mitigate these side effects while improving treatment efficacy.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of obstructive sleep apnea (OSA) as an alternative to Positive Airway Pressure (PAP) therapy. The primary treatment for OSA remains PAP therapy, which includes CPAP, BPAP, and APAP devices. While pharmacological agents are being studied in combination with PAP therapy to improve outcomes, no specific drug has been approved for this purpose. Research continues to explore effective medications that could be used alongside PAP therapy to normalize respiration in patients with sleep apnea.

What other types of research exist?

Currently, the context does not provide specific novel alternatives to Positive Airway Pressure (PAP) plus pharmacological agents for sleep apnea treatment. However, ongoing research aims to identify mechanistic pathways and combination therapies to improve treatment efficacy. Patients should consult with their healthcare providers for the latest updates and personalized treatment options.

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Combination Therapies for Central Sleep Apnea (CSA Trial)

Phase 4

Recruiting

Led By M Safwan Badr, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments

Be older than 18 years old

Must not have

Significant insomnia

Less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial tests a combination of a machine that keeps airways open and medications to improve breathing in patients with central sleep apnea who have heart failure or use opioid painkillers. The goal is to make breathing more stable and less sensitive to disruptions during sleep. A specific type of machine has been studied as a treatment for central sleep apnea in heart failure patients, showing mixed results in improving outcomes.

Who is the study for?

This trial is for Veterans with central sleep apnea, where they stop breathing frequently during sleep. Participants must have a specific severity of the condition and not be pregnant, breastfeeding, or have severe insomnia or respiratory diseases. They should also not be extremely overweight or mentally unstable.

What is being tested?

The study tests if combining positive airway pressure (PAP) therapy with one of three drugs—Acetazolamide, Buspirone, or Zolpidem—can better treat central sleep apnea in patients with heart failure or those using opioid analgesics.

What are the potential side effects?

Possible side effects from the treatments could include tingling sensations and dizziness from Acetazolamide; drowsiness and nausea from Buspirone; and daytime drowsiness or feeling 'drugged' after taking Zolpidem.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a veteran with central sleep apnea, with more than 15 breathing pauses per hour and more than 5 of those are central apneas.

Exclusion Criteria

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

Select...

I have severe trouble sleeping.

Select...

I am under 18 years old.

Select...

I need oxygen therapy for my severe respiratory condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

CO2 reserve

Central apnea indices

Secondary study objectives

% stable breathing

Carotid body function

Controller gain

+3 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Active Control

Group I: buspironeActive Control1 Intervention

To determine the effect of augmenting serotonin A1 receptor activity on breathing during sleep. The investigators hypothesize that administration of PAP and buspirone, a serotonin A1 receptor agonist; will reduce the propensity to central apnea during sleep in Veterans with CSA compared to PAP plus placebo.

Group II: acetazolamideActive Control1 Intervention

To determine the effect of dampening chemoreceptor sensitivity AND decreasing plant gain. The investigators hypothesize that combined therapy with PAP, acetazolamide and oxygen will be superior to PAP plus each intervention alone or placebo in reducing CAHI and the CO2 reserve during sleep in Veterans with CSA.

Group III: zolpidemActive Control1 Intervention

To determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of PAP and zolpidem, will decrease respiratory-related arousals, CAHI and the CO2 reserve during sleep in Veterans with CSA compared to PAP plus placebo.

0 / 4Eligibility 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

The most common treatments for Sleep Apnea include Positive Airway Pressure (PAP) therapy and pharmacological agents. PAP therapy, such as CPAP, APAP, and ASV, works by delivering continuous or variable air pressure to keep the airways open during sleep, preventing apneas and improving oxygenation. Pharmacological agents may target underlying conditions like heart failure or opioid-induced central sleep apnea. Combining these therapies can address both mechanical obstructions and physiological factors, potentially leading to more effective and comprehensive management of Sleep Apnea, improving patient outcomes and quality of life.

Sleep apnea and pulmonary hypertension: A riddle waiting to be solved.Non-invasive ventilation for obese patients with chronic respiratory failure: Are two pressures always better than one?Current Treatment of Comorbid Insomnia and Obstructive Sleep Apnea With CBTI and PAP-Therapy: A Systematic Review.