Trials
Search / Trial NCT06442488

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

Launched by JEFFREY JOSEPH · May 29, 2024

Trial Information

Current as of February 14, 2025

Recruiting

Keywords

Respiratory Monitoring System Detection Of Respiratory Insufficiency Prediction Of Respiratory Insufficiency Wearable, Wireless Respiratory Sensor

ClinConnect Summary

This clinical trial is looking at a new wearable device designed to monitor breathing patterns in people who may be at risk of breathing problems caused by opioid medications. The device, called a Respiratory Monitoring System (RMS), will help researchers see how well it can measure important breathing information, even in noisy environments. The goal is to see if this technology can accurately detect when someone's breathing is getting worse, which is important for keeping patients safe.

To participate in this study, individuals need to be between 18 and 70 years old and have a body mass index (BMI) between 20 and 38. Participants should be able to understand English and provide written consent. Unfortunately, those with certain conditions, such as anxiety related to wearing a face mask or specific skin issues, may not be eligible. If someone joins the study, they can expect to wear the device while researchers gather data on their breathing. This information could help improve safety for patients using opioids in the future.

Gender

ALL

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.

About Jeffrey Joseph

Jeffrey Joseph is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on collaboration and ethical practices, Jeffrey Joseph facilitates the design and execution of clinical trials across various therapeutic areas. The organization prioritizes patient safety and data integrity, ensuring that all trials adhere to rigorous regulatory standards. By fostering partnerships with healthcare professionals and research institutions, Jeffrey Joseph aims to contribute valuable insights to the scientific community and enhance the development of effective therapies.

Locations

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0