CompletedNot Applicable

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

United States14 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 90 minutes

Trial details

NCT IDNCT06442488

SponsorJeffrey Joseph

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Respiratory Insufficiency trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 90 minutes