Clinical trial for Sleep Disordered Breathing
Official title Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
ClinicalTrials.gov ID: NCT07210606
What this study is testing
What is Trazodone + positive airway pressure (PAP) therapy?
An investigational combination of a medication and PAP therapy being studied as a potential treatment for central sleep apnea in patients with heart failure or opioid use. Trazodone is designed to increase serotonin activity, which may influence the brain's control of breathing.
Also referred to as Trazodone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how combined breathing support and a drug affect central sleep apnea and to identify pathways for future treatments.
- Who it's for
- Adults with heart failure or who use opioid pain medicines who also have central sleep apnea.
- What's involved
- Participants will use a positive airway pressure device and take a study medication, with regular clinic visits and breathing tests.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included with the...
- Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations...
You likely can't join if
- Pregnant or breastfeeding females
- Moderate or severe obstructive or restrictive lung disease, including supplemental oxygen (O2) use
- Current treatment for central sleep apnea (CSA), including any form of positive airway pressure (PAP) in the past three months, or phrenic nerve...
- Too ill to engage in the study procedures, inability to provide consent for participation
- A history of cardiac arrhythmia
- Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program
See the full eligibility criteria
- Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included with the experiments
- Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations or change in the medical regimen for the past 90 days before enrollment
- Pregnant or breastfeeding females
- Moderate or severe obstructive or restrictive lung disease, including supplemental oxygen (O2) use
- Current treatment for central sleep apnea (CSA), including any form of positive airway pressure (PAP) in the past three months, or phrenic nerve situation
- Too ill to engage in the study procedures, inability to provide consent for participation
- A history of cardiac arrhythmia
- Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program
- Depression or a history of suicidality
- Severe insomnia (ISI\>21) or reported short sleep duration (\<6 hours)
- Positive airway pressure (PAP)-emergent central sleep apnea
- Prolonged QT on baseline electrocardiogram (ECG), using medications that inhibit CYP3A4
- Patients with severe renal impairment (glomerular filtration rate (GFR) \< 20 milliliters per minute/1.73 square meters) or end-stage renal disease
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.