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Cognitive Training in Mild Cognitive Impairment

Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04899089
Acronym
TRAIN-MCI
Enrollment
48
Registered
2021-05-24
Start date
2021-07-28
Completion date
2023-06-01
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Mild Cognitive Impairment

Keywords

cognitive training, insomnia, mild cognitive impartment, older adults, sleep, cognition

Brief summary

Older adults (60+ years of age) who meet criteria for mild cognitive impairment and insomnia will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and arousal at baseline, and post-intervention. For cognitive training, participants will be provided with login information to access the computerized training, and will complete 8 weeks (45 mins 3x/week) of cognitive training. For trivia training, participants will receive weekly emails that contain trivia assignments that they will complete for 8 weeks (45 mins 3x/week). We will evaluate short-term (i.e., post-training) effects of the two training conditions on subjective anxiety, sleep, arousal, and subjective and objective cognition.

Interventions

BEHAVIORALCognitive Training

The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.

BEHAVIORALTrivia Training

The computerized trivia training asks participants to answer general questions related to pop culture, science, geography, etc. Participants can use online sources to search for answers and will be provided feedback on their accuracy.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 60+ yrs of age 2. meet criteria for mild cognitive impairment 3. no neurological or psychiatric illness or dementia 4. non-gamers (\<2 hour of video/brain training games/week over last 2 yrs) 5. proficient in English (reading and writing) 6. meet clinical dx criteria for Insomnia (e.g., insomnia complaints for 6+ months, complaints occur despite adequate opportunity and circumstances for sleep, consist of one of the following: difficulty falling asleep, staying asleep, or waking up too early, and daytime dysfunction due to insomnia)

Exclusion criteria

1. unable to provide informed consent 2. unable to undergo randomization 3. other sleep disorder (e.g., sleep apnea, restless legs syndrome) 4. severe untreated psychiatric comorbidity 5. psychotropic or other medications that alter sleep (unless stabilized for 6 months) 6. uncorrected visual/auditory impairments 7. participation in nonpharmacological tx for sleep/fatigue/mood/cognition outside the current study

Design outcomes

Primary

MeasureTime frameDescription
Objective Cognition - Computerized Cognitive TasksUp to 10 weeksComplete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).
Subjective Cognitive Self-Efficacy. - Cognitive Failures QuestionnaireUp to 10 weeksA 25 item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Subjective Behavioral Sleep- Electronic Daily Sleep DiariesUp to 10 daysElectronic Daily Sleep Diaries. Online diaries completed each morning (\ 5 mins) during the study. Diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
Subjective Behavioral Sleep- Insomnia Severity IndexUp to 10 weeksBrief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Objective Sleep-WatchpatUp to 10 weeksSingle night objective sleep recording via a wrist worn device.

Secondary

MeasureTime frameDescription
Subjective Arousal- Arousal Predisposition ScaleUp to 10 weeksArousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.
Game Engagement QuestionnaireUp to 10 weeksQuestionnaire assessing the experience of the game.
Mood-Depression-Beck Depression Inventory-IIUp to 10 weeks21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.
Physiological Arousal- Heart Rate VariabilityImpact of game related experience will be measured at baselineCorSense monitor assessed 5 min heart rate recordings both at rest. Time index variables: SDNN (standard deviation of normal to normal heartbeat intervals)
Physical Activity - International Physical Activity QuestionnaireUp to 10 weeks7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
Personality - Big Five InventoryBaseline10 question assessment measuring personality
Computer Proficiency- Computer Proficiency QuestionnaireBaselineThis questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
Alcohol Use - Alcohol Use Disorder TestBaseline10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Anxiety - State-Trait Anxiety InventoryUp to 10 weeksInventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
Game-related experience- Sessions and duration playedUp to 10 weeksDuring the intervention phase the cognitive training group will play games and will need to log the days and duration played.
Circadian Rhythm- Morningness-Eveningness QuestionnaireUp to 10 weeks19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of morningness or eveningness type.
Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress ScaleUp to 10 weeksPerceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026