- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282642
Playing Cognitive Games For Older Adults With Insomnia (PLAY)
August 28, 2023 updated by: Ashley Curtis, University of Missouri-Columbia
Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- University of Missouri
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Training
Computerized Cognitive Training
|
Participants (n=20) provided game console with cognitive training games and activities.
|
Experimental: WLC
Waitlist Control
|
Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks.
|
Objective Sleep-PSG
Time Frame: Up to 15 weeks
|
Single night PSG measured sleep stages.
|
Up to 15 weeks
|
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.
|
Up to 6 weeks
|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
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).
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
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.
|
Baseline
|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
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.
|
Up to 15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashley Curtis, PhD, University of Missouri- School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (Actual)
February 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018341
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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