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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days

Awards & highlights

CSA Trial Summary

This trial is investigating ways to better treat central sleep apnea, a breathing disorder which is common in patients with heart failure or those using pain medications. Current treatment for central sleep apnea is positive airway pressure therapy, which is not very effective. The goal of this proposal is to find new, better ways to treat central sleep apnea by testing combination therapies including positive airway pressure and a pharmacological agent. The investigators hope that the findings of this trial will help to improve treatment and quality of life for Veterans suffering from central sleep apnea.

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.Check my eligibility

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.See study design

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.

CSA Trial 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.

CSA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CO2 reserve

Central apnea indices

Secondary outcome measures

% stable breathing

Carotid body function

Controller gain

+3 more

CSA 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 / 1Eligibility 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.