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Boost Study 21270 (Cognition)

NCT ID: NCT05990335

Last Updated: 2024-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2023-03-27

Brief Summary

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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

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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.

Conditions

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Cognitive Function Abnormal

Keywords

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cognition exercises group I

Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions

Group Type EXPERIMENTAL

mHealth application (custom)

Intervention Type BEHAVIORAL

Smartphone based application designed to engage user executive functions

Cognition exercises group C

Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions

Group Type ACTIVE_COMPARATOR

mHealth application (custom)

Intervention Type BEHAVIORAL

Smartphone based application designed to engage user executive functions

Interventions

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mHealth application (custom)

Smartphone based application designed to engage user executive functions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kansas State University

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

NXTech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Travis Smith

Role: STUDY_DIRECTOR

Kansas State

Locations

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Kansas State DPS

Manhattan, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R43DA051270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NX-21270

Identifier Type: -

Identifier Source: org_study_id