Recruiting

Observational Study

Sponsor:

RTM Vital Signs, LLC

Code:

NCT03845699

Conditions

Drug Overdose

Opioid-Related Disorders

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Diagnostic algorithms that detects/predicts hypoventilation

Study Details

Brief 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.

Conditions

Drug Overdose

Opioid-Related Disorders

Study ID

NCT03845699

Start date

May 15, 2019

Status verified date

May, 2019

Completion date

May 14, 2020

Anticipated

Primary completion date

May 14, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy women/men between 18 and 40 years of age.
2. Negative history of drug or alcohol abuse.
3. Negative history of cigarette smoking in previous 6 months.
4. Negative history of active cardiac, vascular, pulmonary, renal, hepatic, nervous, metabolic or immune disease.
5. BMI < 30

Exclusion Criteria:

1. Age < 18 years and > 40 years.
2. Pregnant or planning to become pregnant.
3. Positive history drug or alcohol abuse.
4. Positive drug screen for opioids, benzodiazepines, hypnotics.
5. Positive Drug Abuse Screening Test result (score of 6 or greater).
6. BMI > 30
7. History of sleep apnea.
8. History of cigarette smoking in previous 6 months.
9. History of difficult airway during anesthesia management.
10. History of allergy or skin sensitivity to tape, silicone, fentanyl, chlorhexidine.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Diagnostic algorithms that detects/predicts hypoventilation

Produce mild and moderate respiratory depression (hypoventilation) using a controlled intravenous infusion of fentanyl while measuring/recording respiratory rate, tidal volume, body activity, and body position.

Primary outcome measure

  • Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Mild Hypoventilation due to an Opioid Overdose [ Time Frame: 1 to 3 hours ]
  • Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Moderate Hypoventilation due to an Opioid Overdose [ Time Frame: 1 to 3 hours ]
  • Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Severe Hypoventilation due to an Opioid Overdose [ Time Frame: 1 to 3 hours ]

Central Contacts and Locations

Central contacts

Stephen McNulty, DO

215-955-6161Stephen.McNulty@Jefferson.edu

Jeffrey I Joseph, DO

215-620-9999Jeffrey.Joseph@Jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Stephen McNulty, DO

215-955-6161Stephen.McNulty@Jefferson.edu

Jeffrey, DO

215-620-9999Jeffrey.Joseph@Jefferson.edu

More Information

Sponsor

RTM Vital Signs, LLC

Last update posted

May 9, 2019

Last verified

May, 2019

Keywords

  • Opioid Overdose
  • Diagnostic Algorithm
  • Wearable Trachea Sound Sensor
  • Respiratory Depression
  • Hypoventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RTM Vital Signs, LLC on 2019-05-09.