Playing Cognitive Games For Older Adults With Insomnia

Study Overview
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Brief Summary
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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

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: WLC (Waitlist Control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training<br>Computerized Cognitive Training | Behavioral: Cognitive Training<br>* Participants (n=20) provided game console with cognitive training games and activities.<br>|
| Experimental: WLC<br>Waitlist Control | Behavioral: WLC (Waitlist Control)<br>* Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire | 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. | Up to 15 weeks | 
| Objective Cognition- NIH Toolbox Cognitive Battery | 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. | Up to 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Behavioral Sleep - Actigraphy | 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. | Up to 15 weeks | 
| Circadian Rhythm - Morningness-Eveningness Questionnaire | 19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of morningness or eveningness type. | Up to 15 weeks | 
| Physiological Arousal- Heart Rate Variability | 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). | Up to 15 weeks | 
| Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale | 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. | Up to 15 weeks | 
| Mood- Beck Depression Inventory (II) | 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. | Up to 15 weeks | 
| Alcohol Use- Alcohol Use Disorder Test | 10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year. | Baseline | 
| Mood- State-Trait Anxiety Inventory | 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. | Up to 15 weeks | 
| Subjective Arousal- Pre-sleep Arousal Scale | Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal. | Up to 15 weeks | 
| Subjective Arousal- Arousal Predisposition Scale | 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. | Up to 15 weeks | 
| Subjective Behavioral Sleep- Electronic Daily Sleep Diaries | 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. | Up to 15 weeks | 
| Subjective Behavioral Sleep- Insomnia Severity Index | Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research. | Up to 15 weeks. | 
| Objective Sleep-PSG | Single night PSG measured sleep stages. | Up to 15 weeks | 
| Game-related experience | During the intervention phase for each group, participants will complete gaming diary measuring session duration, games played. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults