NCT04282642

Brief Summary

The purpose of this research is to look at the effects of computerized cognitive training on sleep, mental abilities (cognition), and other aspects of daytime functioning, such as mood, and arousal

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

February 13, 2020

Last Update Submit

August 28, 2023

Conditions

Insomnia

Keywords

InsomniaCognitive trainingSleepCognitionPolysomnographyActigraphyOlder Adults

Outcome Measures

Primary Outcomes (2)

  • Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire

    A 25-item scale measuring subjective cognition. Participants rate on a scale of 0 (never) to 4 (very often) how often they experience cognitive mistakes and errors in daily tasks.

    Up to 15 weeks

  • Objective Cognition- NIH Toolbox Cognitive Battery

    20-min computerized battery completed in single sitting on iPad.Domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory.

    Up to 15 weeks

Secondary Outcomes (13)

  • Objective Behavioral Sleep - Actigraphy

    Up to 15 weeks

  • Circadian Rhythm - Morningness-Eveningness Questionnaire

    Up to 15 weeks

  • Physiological Arousal- Heart Rate Variability

    Up to 15 weeks

  • Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale

    Up to 15 weeks

  • Mood- Beck Depression Inventory (II)

    Up to 15 weeks

  • +8 more secondary outcomes

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Computerized Cognitive Training

Behavioral: Cognitive Training

WLC

EXPERIMENTAL

Waitlist Control

Behavioral: WLC (Waitlist Control)

Interventions

Cognitive TrainingBEHAVIORAL

Participants (n=20) provided game console with cognitive training games and activities.

Cognitive Training
WLC (Waitlist Control)BEHAVIORAL

Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.

WLC

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + yrs of age.
  • No neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins.
  • Nongamers (i.e. \<1 hour of video/cognitive training games per week over last 2 years)
  • Proficient in English (reading and writing).
  • Meet clinical diagnosis for Insomnia.
  • Insomnia:
  • Insomnia complaints for 6+ months.
  • Complaints occur despite adequate opportunity and circumstances for sleep.
  • Consist of 1+ of the following: difficulty falling asleep, staying asleep, or waking up too early
  • Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia.

You may not qualify if:

  • Unable to provide informed consent.
  • Unable to undergo randomization.
  • Cognitive impairments (i.e. mild cognitive impairment, dementia)
  • Other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder)
  • Severe untreated psychiatric comorbidity that renders randomization unethical
  • Using psychotropic or other medications (e.g., beta-blockers) that alter sleep
  • Uncorrected visual/auditory impairments
  • Participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ashley Curtis, PhD

    University of Missouri- School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to either the cognitive training or waitlist control(WLC). In both conditions, they will receive the intervention, but the waitlist control will receive this later. Both groups will complete 6 weeks of the cognitive training game either immediately after 1 week baseline (cognitive training group) or after the week 8 assessments (WLC).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 25, 2020

Study Start

March 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)