Playing Cognitive Games For Older Adults With Insomnia

NCT ID: NCT04282642

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-05-01

Brief Summary

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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

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Training

Computerized Cognitive Training

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

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

WLC

Waitlist Control

Group Type EXPERIMENTAL

WLC (Waitlist Control)

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Training

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

Intervention Type BEHAVIORAL

WLC (Waitlist Control)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 60+ 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Academy of Sleep Medicine

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Ashley Curtis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashley Curtis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri- School of Medicine

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2018341

Identifier Type: -

Identifier Source: org_study_id

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