Playing Cognitive Games For Older Adults With Insomnia (PLAY)

• ClinicalTrials.gov Identifier: NCT04282642
• Recruitment Status: Recruiting
• First Posted: February 25, 2020
• Last Update Posted: March 24, 2020
• Sponsor: University of Missouri-Columbia
• Collaborator: American Academy of Sleep Medicine Foundation
• Information provided by (Responsible Party): Ashley Curtis, University of Missouri-Columbia

Tracking Information

• First Submitted Date: February 13, 2020
• First Posted Date: February 25, 2020
• Last Update Posted Date: March 24, 2020
• Actual Study Start Date: March 1, 2020
• Estimated Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 20, 2020)

• 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.
• 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.
• Objective Physiological Sleep [ Time Frame: Up to 15 weeks ]
  Single night PSG measured sleep stages.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 20, 2020)

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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).

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Insomnia

Intervention

• Behavioral: Cognitive Training
  Participants (n=20) provided game console with cognitive training games and activities.
• Behavioral: WLC (Waitlist Control)
  Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.

Study Arms

• Experimental: Cognitive Training
  Computerized Cognitive Training
  Intervention: Behavioral: Cognitive Training
• Experimental: WLC
  Waitlist Control
  Intervention: Behavioral: WLC (Waitlist Control)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 20, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2021
• Estimated Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Jacob Wilhelm, M.Ed; 573-884-3293; cashlab@health.missouri.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04282642
• Other Study ID Numbers: 2018341
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Ashley Curtis, University of Missouri-Columbia
• Study Sponsor: University of Missouri-Columbia
• Collaborators: American Academy of Sleep Medicine Foundation

Investigators

• Principal Investigator: Ashley Curtis, PhD; University of Missouri- School of Medicine

• PRS Account: University of Missouri-Columbia
• Verification Date: March 2020