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NCT04071145 Clinical Trial

Using Sensors to Measure Drug Concentrations in Exhaled Breath

Mental Disorder Clinical Trial

Official title:
Using Sensors to Measure Drug Concentrations in Exhaled Breath

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04071145
Other study ID # 6419-19-SMC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2019
Est. completion date October 2020

Study information
Verified date August 2019
Source The Chaim Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date October 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nadav Goldental

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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