Playing Cognitive Games For Older Adults With Insomnia (PLAY)
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|ClinicalTrials.gov Identifier: NCT04282642|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Cognitive Training Behavioral: WLC (Waitlist Control)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|Official Title:||Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia|
|Actual Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: Cognitive Training
Computerized Cognitive Training
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282642
|Contact: Jacob Wilhelm, M.Edfirstname.lastname@example.org|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65201|
|Contact: Ashley Curtis, PhD|
|Principal Investigator: Ashley Curtis, PhD|
|Principal Investigator:||Ashley Curtis, PhD||University of Missouri- School of Medicine|