Combination Therapy for Central Sleep Apnea
(CSA-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks better treatments for central sleep apnea, a condition that disrupts breathing during sleep, particularly in individuals with heart failure or those using opioid painkillers. Researchers are testing whether combining positive airway pressure (PAP) with trazodone, an antidepressant, or with oxygen, enhances breathing more effectively than PAP alone. Suitable participants have central sleep apnea and stable heart failure, with no recent changes in heart treatment. The trial aims to improve care and quality of life for those facing this challenging condition. As a Phase 4 trial, the treatment is already FDA-approved and effective, and this research aims to understand its benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications that inhibit CYP3A4, you may not be eligible to participate.
What is the safety track record for these treatments?
A previous study found that trazodone significantly reduced breathing problems in patients with obstructive sleep apnea without causing major side effects. However, it is not recommended for individuals with central sleep apnea, as it might worsen the condition. While trazodone is generally safe, its effects on central sleep apnea remain unclear.
Research has shown that oxygen therapy can improve sleep quality in people with central sleep apnea, particularly those with heart problems. However, results are mixed, and the long-term benefits are not fully understood. Oxygen is generally safe, but its effectiveness compared to other treatments is still under investigation.
Both trazodone and oxygen have been used before, but their specific effects on central sleep apnea are still being studied. Participants should consider these findings when deciding whether to join a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for central sleep apnea because they offer new ways to enhance the effectiveness of existing therapies. Trazodone is unique because it aims to dampen respiratory arousals and widen the CO2 reserve during sleep, potentially making it superior when combined with CPAP therapy. On the other hand, using supplemental oxygen targets the sensitivity of peripheral chemoreceptors, which could also widen the CO2 reserve and improve sleep quality beyond what CPAP alone can achieve. Both approaches offer novel mechanisms that could lead to better management of central sleep apnea symptoms.
What evidence suggests that this trial's treatments could be effective for central sleep apnea?
This trial will compare the effects of trazodone and oxygen therapy for central sleep apnea. Studies have shown that trazodone, which participants in this trial may receive, can help people stay asleep longer by making it harder to wake up, even if their breathing is interrupted. This might reduce the severity of sleep apnea episodes. Research also suggests that trazodone could improve sleep apnea by changing how the brain reacts to carbon dioxide buildup during sleep.
Oxygen therapy, another treatment option in this trial, has shown promise in helping with central sleep apnea, especially in people with heart failure. Combining oxygen with other treatments like CPAP has been effective for some patients. However, its effectiveness on its own varies, as some studies suggest it doesn't significantly reduce apnea events for everyone.16789Who Is on the Research Team?
M Safwan Badr, MD
Principal Investigator
John D. Dingell VA Medical Center, Detroit, MI
Are You a Good Fit for This Trial?
This trial is for heart failure patients with central sleep apnea, which can include those affected by Cheyne-Stokes respiration or opioid use. Participants should be able to perform daily activities without assistance. People with other types of sleep apnea or conditions that might interfere with the study are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combination therapies including positive airway pressure (PAP) plus a pharmacological agent or supplemental oxygen to address central sleep apnea.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxygen
- Trazodone
Trial Overview
The study tests if combining Trazodone or Oxygen with Positive Airway Pressure (PAP) therapy improves breathing patterns in heart failure patients with central sleep apnea, compared to PAP alone. It aims to find better treatments by understanding how these combinations affect respiratory mechanisms.
How Is the Trial Designed?
2
Treatment groups
Active Control
To determine the effect of dampening respiratory arousals. The investigators hypothesize that PAP therapy with trazodone at 100 mg will be superior to CPAP alone in widening the CO2 reserve during sleep, decreasing respiratory arousals, and increasing the arousal threshold.
To determine the effect of dampening peripheral chemoreceptor sensitivity. The investigators hypothesize that supplemental oxygen will be superior to CPAP alone in widening the CO2 reserve during sleep. The secondary analysis will use CAI as supplemental oxygen, which may obscure the detection of hypopneas based on desaturation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
Central Sleep Apnea - StatPearls - NCBI Bookshelf
Effectiveness of short-term treatment with nocturnal oxygen therapy for central sleep apnea in patients with congestive heart failure. J Cardiol. 2005 Aug ...
Treatment of Central Sleep Apnea in US Veterans
CPAP was effective in 48%, while CPAP+O2 combination was effective in an additional 25%, and BPAP+O2 in 11%. The remaining 16% were non-responders. Forty-seven ...
Nocturnal supports for patients with central sleep apnea and ...
Compared with the control group, all therapeutic regimens (ASV, oxygen therapy, CPAP) did not decrease the apnea hypopnea per hour in all patients with the OR ( ...
Nocturnal Oxygen Therapy for Central Sleep Apnea in ...
Conclusions: While NOT improves CSA and overnight oxygenation, this prematurely terminated study does not provide support for the clinical ...
Evaluation and Treatment of Central Sleep Apnea in ...
In a study by Kaneko et al., CPAP therapy for OSA showed an average improvement of 9% in LVEF in HFrEF patients. However, CPAP has been studied largely in ...
Treatment of Central Sleep Apnea in Adults:
The analysis. 673 demonstrated an increase in sleep quality from baseline favoring the oxygen group (MD 10.30, 95% CI: -4.87 to. 674. 25.46; n=22) The duration ...
Oxygen Therapy in Sleep-Disordered Breathing
In conclusion, studies are inconclusive or limited regarding clinical outcomes with oxygen therapy compared with sham or PAP therapy in patients with OSA and ...
Frequency and outcomes of primary central sleep apnea in a ...
Primary central sleep apnea (PCSA) is believed to be rare and data regarding its prevalence and long-term outcomes are sparse.
NCT03745898 | The Impact of Low Flow Nocturnal Oxygen ...
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart ...
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