Playing Cognitive Games For Older Adults With Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Cognitive Training; Behavioral: WLC (Waitlist Control)

• Registration Number: NCT04282642
• Lead Sponsor: University of Missouri-Columbia

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 available

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-25
• Study Start: 2020-03-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cognitive Training	Cognitive Training	Computerized Cognitive Training
WLC	WLC (Waitlist Control)	Waitlist Control

Primary Outcome Measures

Name	Time	Method
Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire	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.
Objective Cognition- NIH Toolbox Cognitive Battery	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 Outcome Measures

Name	Time	Method
Physiological Arousal- Heart Rate Variability	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).
Mood- Beck Depression Inventory (II)	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.
Objective Behavioral Sleep - Actigraphy	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	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.
Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale	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.
Mood- State-Trait Anxiety Inventory	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	Up to 15 weeks	Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries	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	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 Sleep-PSG	Up to 15 weeks	Single night PSG measured sleep stages.
Subjective Arousal- Arousal Predisposition Scale	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.
Game-related experience	Up to 6 weeks	During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.
Alcohol Use- Alcohol Use Disorder Test	Baseline	10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States