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Playing Cognitive Games For Older Adults With Insomnia

Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04282642
Acronym
PLAY
Enrollment
42
Registered
2020-02-25
Start date
2020-03-01
Completion date
2022-05-01
Last updated
2023-08-30

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

Conditions

Insomnia

Keywords

Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults

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

Interventions

BEHAVIORALCognitive Training

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

BEHAVIORALWLC (Waitlist Control)

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

Sponsors

American Academy of Sleep Medicine
CollaboratorOTHER
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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).

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective Cognitive Self-Efficacy- Cognitive Failures QuestionnaireUp to 15 weeksA 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.
Objective Cognition- NIH Toolbox Cognitive BatteryUp to 15 weeks20-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.

Secondary

MeasureTime frameDescription
Physiological Arousal- Heart Rate VariabilityUp to 15 weeksHolter monitor assessed 5 min ECG recordings both at rest and during sleep (with PSG).Time index variables: SDNN (standard deviation of normal to normal heartbeat intervals). Spectral index variables: High frequency (0.15-0.4 Hz), low frequency (0.04-0.15 Hz), very low frequency (below 0.04 Hz).
Subjective Arousal-Global Cognitive Arousal-Perceived Stress ScaleUp to 15 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 likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.
Mood- Beck Depression Inventory (II)Up to 15 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.
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.
Mood- State-Trait Anxiety InventoryUp to 15 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.
Objective Behavioral Sleep - ActigraphyUp to 15 weeksActiwatch 2 (Philips Respironics) is a watch-like device that monitors light and motor activity. Device is worn 24 hours a day for 7 days at each assessment, and during 6 weeks of intervention. Data analyzed by proprietary software using 30s epochs. Validated algorithm will be used to obtain sleep onset latency, wake time after sleep onset.
Subjective Arousal- Arousal Predisposition ScaleUp to 15 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.
Subjective Behavioral Sleep- Electronic Daily Sleep DiariesUp to 15 weeksElectronic Daily Sleep Diaries. Online diaries completed each morning (\ 5 mins) during 1 wk assessment period and 6 weeks of intervention. Diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
Subjective Behavioral Sleep- Insomnia Severity IndexUp to 15 weeks.Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Objective Sleep-PSGUp to 15 weeksSingle night PSG measured sleep stages.
Game-related experienceUp to 6 weeksDuring the intervention phase for each group, participants will complete gaming diary measuring session duration, games played.
Subjective Arousal- Pre-sleep Arousal ScaleUp to 15 weeksPre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
Circadian Rhythm - Morningness-Eveningness QuestionnaireUp to 15 weeks19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of morningness or eveningness type.

Countries

United States

Outcome results

None listed

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