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

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Conditions

Respiratory InsufficiencyClinical DeteriorationRespiratory Monitoring SystemDetection of Respiratory InsufficiencyPrediction of Respiratory InsufficiencyWearable, Wireless Respiratory Sensor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An observational study will be conducted in approximately 14 participants to evaluate the ability of a wearable, wireless acoustic Respiratory Monitoring System (RMS) to accurately measure a participant's respiratory rate, tidal volume, minute ventilation, and duration of apnea in a noisy environment. Sensor accuracy will be measured with adaptive filtering and active noise cancellation turned on versus turned off.

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06442488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Study Locations (Sites)

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Jeffrey Joseph

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2024-09-30

Terms related to this study

Keywords Provided by Researchers

  • Respiratory Monitoring System
  • Detection of Respiratory Insufficiency
  • Prediction of Respiratory Insufficiency
  • Wearable, Wireless Respiratory Sensor

Additional Relevant MeSH Terms

  • Respiratory Insufficiency
  • Clinical Deterioration