Boost Study 21270 (Cognition)

NCT05990335 | Completed Early Phase 1 Results

• 2 other identifiers: NX-21270R43DA051270
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function Abnormal

Keywords

Cognition

Outcome Measures

Primary Outcomes (1)

• Task Completion Rate

  Percentage of participants completing minimum required weekly interactions

  At 8 weeks

Secondary Outcomes (1)

• Change in Task Performance

  At 8 weeks

Study Arms (2)

Cognition exercises group I

EXPERIMENTAL

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

Behavioral: mHealth application (custom)

Cognition exercises group C

ACTIVE COMPARATOR

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

Behavioral: mHealth application (custom)

Interventions

mHealth application (custom) BEHAVIORAL

Smartphone based application designed to engage user executive functions

Cognition exercises group C; Cognition exercises group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• NXTech: lead
• Kansas State University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kansas State DPS

Manhattan, Kansas, 66506, United States

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Kansas State

external+studydirector@nxtech.co

(785) 532-6850

Study Officials

• Travis Smith

  Kansas State

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 14, 2023
• Study Start: April 18, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)