Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose (NCT03845699) | Clinical Trial Compass
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Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
United States20 participantsStarted 2019-05-15
Plain-language summary
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and severe hypoventilation (respiratory depression) due to an opioid overdose. The purpose of this clinical trial is to develop/validate diagnostic algorithms capable of detecting/predicting the onset of hypoventilation induced by a controlled intravenous infusion of fentanyl. The wearable sensor and algorithms will provide a series of alerts and alarms to the person, caregiver, and/or emergency personnel.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy women/men between 18 and 40 years of age.
. Negative history of drug or alcohol abuse.
. Negative history of cigarette smoking in previous 6 months.
. Negative history of active cardiac, vascular, pulmonary, renal, hepatic, nervous, metabolic or immune disease.
. BMI \< 30
Exclusion criteria
. Age \< 18 years and \> 40 years.
. Pregnant or planning to become pregnant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Mild Hypoventilation due to an Opioid Overdose
Timeframe: 1 to 3 hours
2
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Moderate Hypoventilation due to an Opioid Overdose
Timeframe: 1 to 3 hours
3
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Severe Hypoventilation due to an Opioid Overdose