Boost Study 21270 (Cognition)

Early Phase 1

Completed

• Conditions: Cognitive Function Abnormal
• Interventions: Behavioral: mHealth application (custom)

• Registration Number: NCT05990335
• Lead Sponsor: NXTech

Brief 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.

Detailed 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 in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.

Study Timeline

• Study Start: 2022-04-18
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-05
• Study First Posted: 2023-08-14
• Results First Submitted: 2024-05-09
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognition exercises group C	mHealth application (custom)	Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions
Cognition exercises group I	mHealth application (custom)	Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions

Primary Outcome Measures

Name	Time	Method
Task Completion Rate	At 8 weeks	Percentage of participants completing minimum required weekly interactions

Secondary Outcome Measures

Name	Time	Method
Change in Task Performance	At 8 weeks	Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week

Trial Locations

Locations (1)

Kansas State DPS; 🇺🇸 Manhattan, Kansas, United States