Using Sensors to Measure Drug Concentrations in Exhaled Breath

NCT04071145 | Unknown

• 1 other identifier: 6419-19-SMC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. Such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis. The current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. The device, SniffPhone, uses sensors to detect and measure volatile organic compounds (VOCs) in exhaled breath, and features a small and portable design. Sniff Phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (2)

• Detection of drug type and concentration in volatile organic compounds (VOCs) profile

  Detection of drug type and concentration in VOCs profile (measured using Sniff Phone)

  Up to 6 months

• Correlation between drug concentration and volatile organic compounds VOC concentrations

  Correlation between drug concentration (as measured in blood test) and VOCs (hexanone acetic acid, heptane, hexanal, 3-heptanone, hexanoic acid, heptanal and nonanal) measured using Sniff Phone.

  Up to 6 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psychiatric patients with traetment plans that require theraputic drug monitoring

You may qualify if:

• Proper ability to give informed consent
• Psychiatric patients undergoing treatment at Sheba Medical Center
• Patients with treatment plans that require therapeutic drug monitoring

You may not qualify if:

• Involuntary psychiatric hospitalization
• Pregnancy

Sponsors & Collaborators

• Nadav Goldental: lead

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08