Playing Cognitive Games For Older Adults With Insomnia

Insomnia Clinical Trial

— PLAY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282642
• Other study ID #: 2018341
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	American Academy of Sleep Medicine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Objective Sleep-PSG	Single night PSG measured sleep stages.	Up to 15 weeks
Secondary	Game-related experience	During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.	Up to 6 weeks