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Playing Cognitive Games For Older Adults With Insomnia (PLAY)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
WLC (Waitlist Control)
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive Training

WLC

Arm Description

Computerized Cognitive Training

Waitlist Control

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
Objective Sleep-PSG
Single night PSG measured sleep stages.
Game-related experience
During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.

Full Information

First Posted
February 13, 2020
Last Updated
August 28, 2023
Sponsor
University of Missouri-Columbia
Collaborators
American Academy of Sleep Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04282642
Brief Title
Playing Cognitive Games For Older Adults With Insomnia
Acronym
PLAY
Official Title
Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
American Academy of Sleep Medicine Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Computerized Cognitive Training
Arm Title
WLC
Arm Type
Experimental
Arm Description
Waitlist Control
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Participants (n=20) provided game console with cognitive training games and activities.
Intervention Type
Behavioral
Intervention Name(s)
WLC (Waitlist Control)
Intervention Description
Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.
Primary Outcome Measure Information:
Title
Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire
Description
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.
Time Frame
Up to 15 weeks
Title
Objective Cognition- NIH Toolbox Cognitive Battery
Description
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.
Time Frame
Up to 15 weeks
Secondary Outcome Measure Information:
Title
Objective Behavioral Sleep - Actigraphy
Description
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.
Time Frame
Up to 15 weeks
Title
Circadian Rhythm - Morningness-Eveningness Questionnaire
Description
19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
Time Frame
Up to 15 weeks
Title
Physiological Arousal- Heart Rate Variability
Description
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).
Time Frame
Up to 15 weeks
Title
Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale
Description
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.
Time Frame
Up to 15 weeks
Title
Mood- Beck Depression Inventory (II)
Description
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.
Time Frame
Up to 15 weeks
Title
Alcohol Use- Alcohol Use Disorder Test
Description
10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Time Frame
Baseline
Title
Mood- State-Trait Anxiety Inventory
Description
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.
Time Frame
Up to 15 weeks
Title
Subjective Arousal- Pre-sleep Arousal Scale
Description
Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
Time Frame
Up to 15 weeks
Title
Subjective Arousal- Arousal Predisposition Scale
Description
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.
Time Frame
Up to 15 weeks
Title
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries
Description
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.
Time Frame
Up to 15 weeks
Title
Subjective Behavioral Sleep- Insomnia Severity Index
Description
Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Time Frame
Up to 15 weeks.
Title
Objective Sleep-PSG
Description
Single night PSG measured sleep stages.
Time Frame
Up to 15 weeks
Title
Game-related experience
Description
During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Curtis, PhD
Organizational Affiliation
University of Missouri- School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States

12. IPD Sharing Statement

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Playing Cognitive Games For Older Adults With Insomnia

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