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Completed

NCT Number: NCT04282642

Playing Cognitive Games For Older Adults With Insomnia

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive training

Behavioral

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

WLC (Waitlist Control)

Behavioral

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

Primary outcomes

  1. Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire

    Time frame: Up to 15 weeks

    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.

  2. Objective Cognition- NIH Toolbox Cognitive Battery

    Time frame: Up to 15 weeks

    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.

Secondary outcomes

  1. Objective Behavioral Sleep - Actigraphy

    Time frame: Up to 15 weeks

    Actiwatch 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.

  2. Circadian Rhythm - Morningness-Eveningness Questionnaire

    Time frame: Up to 15 weeks

    19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.

  3. Physiological Arousal- Heart Rate Variability

    Time frame: Up to 15 weeks

    Holter 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).

  4. Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale

    Time frame: Up to 15 weeks

    Perceived 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.

  5. Mood- Beck Depression Inventory (II)

    Time frame: Up to 15 weeks

    21-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.

  6. Alcohol Use- Alcohol Use Disorder Test

    Time frame: Baseline

    10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

  7. Mood- State-Trait Anxiety Inventory

    Time frame: Up to 15 weeks

    Inventory 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.

  8. Subjective Arousal- Pre-sleep Arousal Scale

    Time frame: Up to 15 weeks

    Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.

  9. Subjective Arousal- Arousal Predisposition Scale

    Time frame: Up to 15 weeks

    Arousal 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.

  10. Subjective Behavioral Sleep- Electronic Daily Sleep Diaries

    Time frame: Up to 15 weeks

    Electronic 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.

  11. Subjective Behavioral Sleep- Insomnia Severity Index

    Time frame: Up 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.

  12. Objective Sleep-PSG

    Time frame: Up to 15 weeks

    Single night PSG measured sleep stages.

  13. Game-related experience

    Time frame: Up to 6 weeks

    During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

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

Acronym: PLAY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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