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

NCT06442488 | Completed FDA Device

• 1 other identifier: 1R44DA059491-01
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency; Clinical Deterioration

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Accuracy of respiratory rate (RR) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.

  RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of RR measurement.

  90 minutes

• Accuracy of tidal volume (TV) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.

  RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of TV measurement.

  90 minutes

• Accuracy of minute ventilation (MV) measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.

  RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of MV measurement.

  90 minutes

• Accuracy of duration of apnea measurement in a noisy environment when RMS adaptive filtering and active noise cancellation is turned on versus turned off.

  RMS breathing data and reference pneumotach/capnogram data will be recorded with RMS adaptive filtering and active noise cancellation turned on and turned off to calculate the accuracy of duration of apnea measurement.

  90 minutes

Secondary Outcomes (1)

• Measure the signal-to-noise ratio of the RMS output signal in a noisy external environment with adaptive filtering and active noise cancellation turned on and off.

  90 minutes

Interventions

Respiratory Monitoring System DEVICE

Comparing the SNR and accuracy of measurement (RR, TV, MV, apnea duration) in a noisy external environment when the RMS has adaptive filtering and active noise cancellation turned on versus turned off.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

14 participants that meet the inclusion/exclusion criteria. Approximately equal number of male/female participants.

You may qualify if:

• Age 18 to 70 years.
• BMI 20 to 38.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jeffrey Joseph: lead
• RTM Vital Signs, LLC: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• Yu L, Ting CK, Hill BE, Orr JA, Brewer LM, Johnson KB, Egan TD, Westenskow DR. Using the entropy of tracheal sounds to detect apnea during sedation in healthy nonobese volunteers. Anesthesiology. 2013 Jun;118(6):1341-9. doi: 10.1097/ALN.0b013e318289bb30.

  PMID: 23407106 BACKGROUND

• Chen G, de la Cruz I, Rodriguez-Villegas E. Automatic lung tidal volumes estimation from tracheal sounds. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1497-500. doi: 10.1109/EMBC.2014.6943885.

  PMID: 25570253 BACKGROUND

• Thakor NV, Zhu YS. Applications of adaptive filtering to ECG analysis: noise cancellation and arrhythmia detection. IEEE Trans Biomed Eng. 1991 Aug;38(8):785-94. doi: 10.1109/10.83591.

  PMID: 1937512 BACKGROUND

• Ramsay MA, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by rainbow acoustic monitoring and capnometry. Anesth Analg. 2013 Jul;117(1):69-75. doi: 10.1213/ANE.0b013e318290c798. Epub 2013 Apr 30.

  PMID: 23632055 BACKGROUND

• Harper VP, Pasterkamp H, Kiyokawa H, Wodicka GR. Modeling and measurement of flow effects on tracheal sounds. IEEE Trans Biomed Eng. 2003 Jan;50(1):1-10. doi: 10.1109/TBME.2002.807327.

  PMID: 12617519 BACKGROUND

• Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.

  PMID: 28448390 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Clinical Deterioration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)