Using Sensors to Measure Drug Concentrations in Exhaled Breath

• Conditions: Mental Disorder

• Registration Number: NCT04071145
• Lead Sponsor: Nadav Goldental

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Study Start: 2019-09
• Primary Completion: 2020-04
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Involuntary psychiatric hospitalization
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between drug concentration and volatile organic compounds VOC concentrations	Up to 6 months	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.
Detection of drug type and concentration in volatile organic compounds (VOCs) profile	Up to 6 months	Detection of drug type and concentration in VOCs profile (measured using Sniff Phone)