Wearable device for monitoring breathing to predict opioid-related respiratory issues

Wearable Wireless Respiratory Monitoring System That Detects and Predicts Opioid Induced Respiratory Depression

This study is testing a new wearable device that monitors breathing to see if it can help predict breathing problems in people using opioids.

Quick facts

• Study type: Observational
• Enrollment: 14 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Thomas Jefferson University (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06442488 on ClinicalTrials.gov

What this trial studies

This observational study evaluates a wearable, wireless Respiratory Monitoring System (RMS) designed to accurately measure respiratory parameters such as respiratory rate, tidal volume, minute ventilation, and apnea duration in noisy environments. The RMS consists of a miniature acoustic sensor adhered to the neck, which captures airflow sounds and uses machine learning algorithms to convert these sounds into vital sign data. The study will involve 14 to 20 participants, with data collected during a single 90-minute session, comparing the RMS measurements to reference data from a hospital ventilator. The goal is to improve the detection and prediction of respiratory compromise in patients receiving opioids.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI between 20 and 38 who can understand and consent to the study.

Not a fit: Patients with unstable health conditions or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this technology could provide timely and accurate monitoring of respiratory function, potentially reducing the risk of opioid-induced respiratory depression.

How similar studies have performed: While similar approaches to respiratory monitoring exist, this specific wearable technology is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 70 years.
2. BMI 20 to 38.
3. Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.

Exclusion Criteria:

1. Age \<18 years\>70.
2. BMI \< 20 or \> 38.
3. Does not understand written and spoken English.
4. Anxiety or claustrophobia related to wearing a face mask.
5. History of skin irritation or inflammation related to the adhesive, adhesive tape, or materials used in the trachea sound sensor or facemask.
6. Active infection or inflammation of the skin above the proximal trachea.
7. Excessive facial hair that may prevent a tight seal around the facemask.
8. Unstable cardiac, vascular, pulmonary, hepatic, renal, immune function at the discretion of the investigator.
9. Pregnancy or breast feeding.
10. Current participation in an industry sponsored pharmaceutical study or a medical device study.

Where this trial is running

Philadelphia, Pennsylvania

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Jeffrey I Joseph, DO

Conditions Respiratory Insufficiency; Clinical Deterioration; Respiratory Monitoring System; Detection of Respiratory Insufficiency; Prediction of Respiratory Insufficiency; Wearable, Wireless Respiratory Sensor