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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0