Clinical trial NCT04282642: Playing Cognitive Games For Older Adults With Insomnia
Official title: Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cognitive training
Sleep
Cognition
Polysomnography
Actigraphy
Older Adults
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2020-02-25
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire
timeFrame: Up to 15 weeks
measure: Objective Cognition- NIH Toolbox Cognitive Battery
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Objective Behavioral Sleep - Actigraphy
timeFrame: Up to 15 weeks
measure: Circadian Rhythm - Morningness-Eveningness Questionnaire
timeFrame: Up to 15 weeks
measure: Physiological Arousal- Heart Rate Variability
timeFrame: Up to 15 weeks
measure: Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale
timeFrame: Up to 15 weeks
measure: Mood- Beck Depression Inventory (II)
timeFrame: Up to 15 weeks
measure: Alcohol Use- Alcohol Use Disorder Test
timeFrame: Baseline
measure: Mood- State-Trait Anxiety Inventory
timeFrame: Up to 15 weeks
measure: Subjective Arousal- Pre-sleep Arousal Scale
timeFrame: Up to 15 weeks
measure: Subjective Arousal- Arousal Predisposition Scale
timeFrame: Up to 15 weeks
measure: Subjective Behavioral Sleep- Electronic Daily Sleep Diaries
timeFrame: Up to 15 weeks
measure: Subjective Behavioral Sleep- Insomnia Severity Index
timeFrame: Up to 15 weeks.
measure: Objective Sleep-PSG
timeFrame: Up to 15 weeks
measure: Game-related experience
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri- School of Medicine
name: Ashley Curtis, PhD
role: PRINCIPAL_INVESTIGATOR
References: