Boost Study 21270 (Cognition)

Cognitive Function Abnormal Clinical Trial

Official title:

Mobile Software Application Intervention Including Cognitive Tasks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990335
• Other study ID #: NX-21270
• Status: Completed
• Phase: Early Phase 1
• Start date: April 18, 2022
• Est. completion date: March 27, 2023

Study information

• Verified date: August 2023
• Source: NXTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.

Description:

The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate for at least 150 min per week in app interaction activities for up to 8 weeks with measures primarily evaluating feasibility of app package task completion, and secondarily evaluating the cognitive effect of these activities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 27, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 years and above
• Fluent in English
• Resides in the United States
• Score on prescreen task is in 25% quartile
• Familiar with smartphone device app installation and device usage
• Possesses a compatible smartphone Exclusion Criteria: None

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Function Abnormal

Intervention

Behavioral:
• mHealth application (custom)
Smartphone based application designed to engage user executive functions

Locations

Country	Name	City	State
United States	Kansas State DPS	Manhattan	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
NXTech	Kansas State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Feasibility (Task Completion)	Number of interaction trials completed (measured as whole number count, per subject, per week)	Weekly, for 8 weeks
Secondary	Task Performance	Baseline (Enrollment) and Postintervention (Week 8)	Weekly, for 8 weeks
Secondary	Usability Rating	DFS UX survey (assessed by Likert scale, 1-5 whole number response per question)	Once, at 8 weeks