Mobile Acoustic Startle Reflex-monitoring System (MARS)

NCT04113850 | Completed

• 1 other identifier: IRB00217977
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of 55 adult male veterans with PTSD. The study will test a new mobile application "app" that can be run on an iPhone10. The app, which is called the Mobile Acoustic startle Reflex-monitoring System (a.k.a., MARS), will be used to measure participant's acoustic startle in sitting or standing postures.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• Acoustic Startle Response (speed)

  The acoustic startle response is the physiological measurement of eye-blink reflex following a sound. In the present protocol, various intensities of sound will be played using specialized equipment that plays sound through noise-cancelling earphones. The acoustic startle measure will be obtained using an "App" on an Apple iPhone 10. The primary startle response outcome is the time in seconds (typically milliseconds) between the playing of the sound, and the individual's eyeblink.

  1 year after initiation of enrollment

Secondary Outcomes (1)

• Acoustic Startle Response (amplitude)

  1 year after the initiation of enrollment

Other Outcomes (1)

• Relationship between acoustic startle reflex and PTSD severity

  1 year after the initiation of enrollment

Study Arms (2)

Sitting

EXPERIMENTAL

Subjects will undergo acoustic startle testing in the sitting position.

Device: Mobile Acoustic startle Reflex monitoring System (MARS)

Standing

EXPERIMENTAL

Subjects will undergo acoustic startle testing in the standing position.

Device: Mobile Acoustic startle Reflex monitoring System (MARS)

Interventions

Mobile Acoustic startle Reflex monitoring System (MARS) DEVICE

Acoustic startle testing

Sitting; Standing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of PTSD

You may not qualify if:

• positive drug or alcohol screen

Sponsors & Collaborators

• Johns Hopkins University: lead
• School of Biomedical Sciences, University of Otago, Dunedin, New Zealand: collaborator
• DigiTheronix: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Una McCann, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study psychiatrist will be blind to MARS results at the time of the psychiatric interview that will confirm PTSD diagnosis and PTSD severity.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, randomized (to sitting or standing postures)

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: November 28, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available to investigators in New Zealand at the time of data analyses, approximately one year after the study has begun.
• Access Criteria: Only Dr. Yusuf Cakmak and data analyst (who will conduct the data analyses) will have access to the data. They will have a copy of the data which will be saved on a secure server.

Locations

US (1)