InsomniaPLAYNCT04282642
Playing Cognitive Games For Older Adults With Insomnia
A study testing Cognitive Training in people with Insomnia, run by University of Missouri-Columbia at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Insomnia
- Being tested
- Cognitive Training, WLC (Waitlist Control)
- Keywords
- Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Participants (n=20) provided game console with cognitive training games and activities.
WLC (Waitlist Control)Behavioural
Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Computerized Cognitive Training Receives: Behavioral: Cognitive Training |
| WLC | Experimental | Waitlist Control Receives: Behavioral: WLC (Waitlist Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
Secondary outcomes (13)
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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).
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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.
Measured: Baseline
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks
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.
Measured: Up to 15 weeks.
Objective Sleep-PSG
Single night PSG measured sleep stages.
Measured: Up to 15 weeks
Game-related experience
During the intervention phase for each group, participants will complete "gaming diary" measuring session duration, games played.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Ashley Curtis, University of Missouri-Columbia
- Investigators
- Ashley Curtis, PhD, Principal investigator, University of Missouri- School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282642
- Sponsor's protocol ID
- 2018341
- Acronym
- PLAY
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia
- ClinicalTrials.gov ID
- NCT04282642
- Acronym / sponsor ID
- PLAY / 2018341
- Conditions
- Insomnia
- Keywords
- Insomnia, Cognitive training, Sleep, Cognition, Polysomnography, Actigraphy, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingComputerized Cognitive Training |
| WLC | Experimental | Behavioral: WLC (Waitlist Control)Waitlist Control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingParticipants (n=20) provided game console with cognitive training games and activities. | Behavioural | Cognitive Training |
| WLC (Waitlist Control)Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments. | Behavioural | WLC |
Primary outcome
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.
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.
13 secondary outcomes
Objective Behavioral Sleep - Actigraphy
Time frame: Up to 15 weeks
Circadian Rhythm - Morningness-Eveningness Questionnaire
Time frame: Up to 15 weeks
Physiological Arousal- Heart Rate Variability
Time frame: Up to 15 weeks
Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale
Time frame: Up to 15 weeks
Mood- Beck Depression Inventory (II)
Time frame: Up to 15 weeks
Alcohol Use- Alcohol Use Disorder Test
Time frame: Baseline
Mood- State-Trait Anxiety Inventory
Time frame: Up to 15 weeks
Subjective Arousal- Pre-sleep Arousal Scale
Time frame: Up to 15 weeks
Subjective Arousal- Arousal Predisposition Scale
Time frame: Up to 15 weeks
Subjective Behavioral Sleep- Electronic Daily Sleep Diaries
Time frame: Up to 15 weeks
Subjective Behavioral Sleep- Insomnia Severity Index
Time frame: Up to 15 weeks.
Objective Sleep-PSG
Time frame: Up to 15 weeks
Game-related experience
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Related trials for Insomnia
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Curtis, PhD principal investigator
University of Missouri- School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Insomnia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire (time frame: Up to 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.