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NCT03788278

An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder

Status unknown Last updated 7 August 2019
What this trial tests

trial testing BioBeat in Post-traumatic Stress Disorder in 50 participants. Status unknown.

Timeline
20 August 2019
Primary endpoint
20 October 2019
1 December 2019

Quick facts

Lead sponsorNadav Goldental
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date20 August 2019
Primary completion20 October 2019
Estimated completion1 December 2019

Drugs / interventions tested

Conditions studied

Sponsor

Nadav Goldental

Who can join

Adults 18 to 120, any sex, with Post-traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Psychiatric diagnosis is based mainly on questioning the patient and subjective impression rather than a quantitative assessment. The assessment is usually done with long time intervals between assessments and arbitrary in relation to the clinical course of the disorder. Post-traumatic stress disorder has physiological, physical, and behavioral manifestations. These changes appear as a response to different situations during the day and can be measured directly and indirectly in order to obtain an objective, quantitative and fuller picture of the severity and changes in the disorder. This is a non-interventional pilot study, using a system that collects data through wearable sensors and smartphone over a long period of time for patients suffering from PTSD and enables data analysis and characterization of a personal digital phenotype using a dedicated algorithm. Based on this pattern, the investigators will attempt to support the establishment of the PTSD diagnosis. During the course of the study, the therapeutic procedure will not be affected by the study and will be independent of the research.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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