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Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment (SHUTi OASIS)

Primary Purpose

Mild Cognitive Impairment, Cognitive Impairment, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Health Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 55 years of age or older

    • ability to read and speak English
    • US resident
    • MCI diagnosis or scores within acceptable range on R-BANS assessment.
    • regular access to Internet and Email
    • willingness to use Internet and Email
    • ability to use a computer
    • no more than 6.5 hours of sleep per night
    • the sleep disturbance (or associated daytime fatigue) must cause significant distress or impairment in social, occupational, or other areas of functioning over past 3 months
    • sleep onset latency > 30 minutes at least 3x/week for past three months; OR wake after sleep onset >30 minutes at least 3x/week for past three months

Participants on stable (defined as no change in the past 3 months) medication regimens will be eligible including sleep medications, unless the medication is known to cause insomnia (e.g., steroids).

Exclusion Criteria:

  • bedtime outside of 8pm-2am and arise times outside of 4-10am

    • current psychological treatment for insomnia
    • initiation of psychological or psychiatric treatment within past 3 months
    • current severe/very severe depression from QIDS-C16
    • current moderate/high risk suicide or substance use disorder in 12 months from MINI
    • other untreated sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome)
    • current diagnosis of Huntington's or Parkinson's disease
    • current treatment for hyperthyroidism
    • currently undergoing chemotherapy
    • presence of asthma or respiratory concerns with night treatment
    • chronic pain treated with opioids
    • epilepsy
    • inability to provide informed consent
    • Not concurrently enrolled in any other intervention or educational study targeting sleep.

Sites / Locations

  • University Of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Internet-Based Insomnia Intervention

Arm Description

2 weeks of online sleep diaries. Participants will also wear an Actiwatch at night, which records measurements of movements of a limb, providing an estimation of sleep duration, sleep pattern and disturbed sleep. 9 week interveition period, subjects complete the internet based CBT-I program, consisting of six Cores (Getting Ready, Sleep Scheduling, Sleep Practices, Thinking Differently, Sleep Hygiene, and Moving On).Each Core takes approximately 45-60 minutes to review online, and most participants spend an additional 30-45 minutes per week on recommended exercises. Participant will then be instructed to complete a post-Assessment, consisting of one online questionnaire and two weeks of Daily Sleep Diaries. The Actiwatch is worn as before during this two week period.

Outcomes

Primary Outcome Measures

Increase in Sleep Duration
Patient generated data on sleep through questionnaires
Increase in Sleep Duration
Patient generated data on sleep through questionnaires
Impact on Psychological Distress
Patient generated data on sleep through questionnaires
Impact on Psychological Distress
Patient generated data on sleep through questionnaires
Impact on Overall Health
Patient generated data on sleep through questionnaires
Impact on Overall Health
Patient generated data on sleep through questionnaires
Impact on Sleep Pattern
Data obtained through wrist actigraphy.
Impact on Sleep Pattern
Data obtained through wrist actigraphy.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
April 26, 2021
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04382365
Brief Title
Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment
Acronym
SHUTi OASIS
Official Title
Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to determine feasibility of an online program providing cognitive behavioral therapy for insomnia in adults with cognitive impairment. The study involves the use an Internet program (website) for 9 weeks. There are two required study visits in the home or in a UVA clinic. Participants will complete online questionnaires and sleep diaries twice during a 4-month period. Participants will also wear a sleep watch for two weeks before and after using the website.
Detailed Description
Mild cognitive impairment in older adults. Mild Cognitive Impairment (MCI) is recognized as an early stage cognitive disorder, a condition where patients live independently and are able to still perform many instrumental activities of daily living.1,2 Individuals with MCI typically present with subtle cognitive changes that can worsen over time.3,4 MCI prevalence is estimated to be as high as 19% among older adults in the US,3,5 with 10-13% progressing to dementia, such as Alzheimer's disease (AD), every year.6-8 With no known cure for MCI, current treatments focus on the maintenance of cognitive function, management of behavioral symptoms, and slowing or delaying the symptoms of disease.9 Characteristics of sleep in MCI and AD. Recent research concludes that individuals with cognitive impairment experience more disruptive sleep and sleep disorders than those without cognitive concerns.10-12 Older adults also more likely to have MCI, and other age-related sleep changes include a decrease in total sleep duration, decreased sleep efficiency, increased sleep fragmentation, increased sleep onset latency, and decreased slow wave and rapid eye movement (REM) sleep. In a review examining the effect of poor sleep on cognitive outcomes, poor sleep was identified as a risk factor for cognitive decline and AD.10 Recent research seeks to understand the mechanisms underlying this relationship using neuroimaging as well as sleep and cognitive functioning data. Although exact mechanisms underlying this relationship are not yet known, and possibly interactive, healthy sleep promotes maintenance of brain health, and may delay symptoms of AD and other dementias.10 Insomnia in older adults. Insomnia affects up to 25% of older adults. It is characterized by difficulty falling asleep and/or maintaining sleep as well as impaired functioning during waking hours.13 Individuals with insomnia have decreased work productivity, more accidents, more hospitalizations, and overall greater healthcare costs compared to their healthy counterparts.14,15 Insomnia symptoms can also affect significant others and caregivers. Specifically, nighttime activities can disrupt partners' sleep, which may impact the ability for him or her to function normally and provide care, as insomnia has been associated with decrease in measures of attention.16,17 Although everyone is at risk for developing insomnia, there are certain factors that increase one's risk. For example, predisposing factors include older age, female gender, and a positive family history of sleep disorders.18 The most common precipitating factors are psychological stress and major life changes. Factors known to perpetuate insomnia are typically behavioral and cognitive reactions, which are learned responses to sleep problems (e.g., daytime napping). Treatment of insomnia. Treatment is recommended in two forms: pharmacological and behavioral-based interventions. Most commonly, sleep disturbances are treated with medication.19 Although pharmacological interventions can be effective in the short-term, they do not treat underlying predisposing, precipitating, and/or perpetuating factors of insomnia. Older adults experience pharmacokinetic and pharmacodynamic changes associated with aging;20 are more susceptible to consequences of potentially inappropriate medications;21 and are most likely to experience negative side-effects of polypharmacy.22 Age-related issues are especially concerning when using traditional benzodiazepines and non-benzodiazepine receptor agonist sleep aids such as zolpidem, eszopiclone, and zaleplon. Use of traditional sleep aids in older adults has been associated with serious adverse events (e.g., cognitive impairment, falls).23,24 Despite evidence regarding adverse consequences, pharmacological treatment of insomnia remains the most common treatment for insomnia. Non-pharmacological treatment of insomnia. Cognitive-Behavioral Treatment for insomnia (CBT-I) is a non-pharmacological intervention that is effective in treating insomnia in older adults, even when present with comorbid medical and psychological conditions.25 CBT-I focuses on the maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems, and typically consists of five primary treatment components: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.26,27 Although there are effective treatments for insomnia, less than 15% of all adults with chronic insomnia are estimated to get any treatment for insomnia.28 Even for those seeking CBT-I, access is extremely limited due to the small number of clinicians trained in behavioral insomnia treatment.29 Internet CBT-I. The Internet has the potential to overcome barriers related to obtaining face-to-face CBT-I. Older adults have historically had limited Internet access, but this is changing dramatically. In 2000, only 14% of adults over the age of 64 used the Internet.30 In 2017, 66% of adults over 65 years of age and 87% age 50-64, reported Internet access.30 Almost 50% of older adults describe the Internet as ''quite a bit'' to ''extremely'' helpful to find new knowledge about their disease, treatment options, and drug therapy.59 Older adults are also more likely to use technology when presented with the potential benefits.57 Internet-delivered interventions for older adults have also been shown to be feasible and effective. For example, Internet-delivered interventions for dementia caregivers improved caregiver confidence, depression, and self-efficacy.31 The CBT-I internet intervention, Sleep Healthy Using Internet (SHUTi) for Older Adult Sufferers of Insomnia and Sleeplessness (OASIS), was developed for adults over age 55. Sleep diaries and actigraphy. Sleep diaries are often used both as a behavioral tool during CBT-I as well as a way to determine the effect of CBT-I on sleep. For the latter, sleep diaries are kept by the patient both prior to and following the intervention and the patient reports on various sleep factors each night. From this self-reported data, sleep variables can be calculated, such as sleep onset latency (SOL), wakefulness after initial sleep onset (WASO), total sleep time (TST), total time spent in bed (TIB), sleep efficiency (SE), and sleep quality.32 This data can also be collected passively through the use of actigraphy. Actigraphy is an objective, non-invasive, and minimally burdensome approach to continuously measure gross motor activity and provide wake/sleep timing. Although actigraphy is considered less reliable in patients with insomnia compared to polysomnography (PSG),33 actigraphy provides the opportunity to collect multiple nights at little to no extra burden to participants. There is also a strong correlation between sleep diaries and actigraphy. Most notably, Chambers34 found a substantial within-participant correlation (r = .80) between actigraph and sleep diaries, and, we plan to use actigraphy for similar within-participant analyses examining sleep variability and patterns. The proposed research focuses on individuals with Mild Cognitive Impairment and insomnia, positing that improved sleep will moderate further cognitive decline. Before undertaking large-scale interventions to determine efficacy of SHUTi OASIS in this population and long-term cognitive outcomes of improved sleep, there must be preliminary work to determine feasibility of delivering the intervention to older adults with MCI and insomnia. To better understand sleep patterns of individuals with MCI and insomnia, actigraphy data will be collected and analyzed to identify within-participant sleep patterns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cognitive Impairment, Insomnia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-Based Insomnia Intervention
Arm Type
Other
Arm Description
2 weeks of online sleep diaries. Participants will also wear an Actiwatch at night, which records measurements of movements of a limb, providing an estimation of sleep duration, sleep pattern and disturbed sleep. 9 week interveition period, subjects complete the internet based CBT-I program, consisting of six Cores (Getting Ready, Sleep Scheduling, Sleep Practices, Thinking Differently, Sleep Hygiene, and Moving On).Each Core takes approximately 45-60 minutes to review online, and most participants spend an additional 30-45 minutes per week on recommended exercises. Participant will then be instructed to complete a post-Assessment, consisting of one online questionnaire and two weeks of Daily Sleep Diaries. The Actiwatch is worn as before during this two week period.
Intervention Type
Other
Intervention Name(s)
Sleep Health Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness
Intervention Description
Cognitive-Behavioral Treatment for insomnia (CBT-I) is a non-pharmacological intervention that is effective in treating insomnia in older adults, even when present with comorbid medical and psychological conditions.25 CBT-I focuses on the maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems, and typically consists of five primary treatment components: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
Primary Outcome Measure Information:
Title
Increase in Sleep Duration
Description
Patient generated data on sleep through questionnaires
Time Frame
Baseline
Title
Increase in Sleep Duration
Description
Patient generated data on sleep through questionnaires
Time Frame
11 weeks
Title
Impact on Psychological Distress
Description
Patient generated data on sleep through questionnaires
Time Frame
Baseline
Title
Impact on Psychological Distress
Description
Patient generated data on sleep through questionnaires
Time Frame
11 weeks
Title
Impact on Overall Health
Description
Patient generated data on sleep through questionnaires
Time Frame
Baseline
Title
Impact on Overall Health
Description
Patient generated data on sleep through questionnaires
Time Frame
11 weeks
Title
Impact on Sleep Pattern
Description
Data obtained through wrist actigraphy.
Time Frame
Baseline
Title
Impact on Sleep Pattern
Description
Data obtained through wrist actigraphy.
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 55 years of age or older ability to read and speak English US resident MCI diagnosis or scores within acceptable range on R-BANS assessment. regular access to Internet and Email willingness to use Internet and Email ability to use a computer no more than 6.5 hours of sleep per night the sleep disturbance (or associated daytime fatigue) must cause significant distress or impairment in social, occupational, or other areas of functioning over past 3 months sleep onset latency > 30 minutes at least 3x/week for past three months; OR wake after sleep onset >30 minutes at least 3x/week for past three months Participants on stable (defined as no change in the past 3 months) medication regimens will be eligible including sleep medications, unless the medication is known to cause insomnia (e.g., steroids). Exclusion Criteria: bedtime outside of 8pm-2am and arise times outside of 4-10am current psychological treatment for insomnia initiation of psychological or psychiatric treatment within past 3 months current severe/very severe depression from QIDS-C16 current moderate/high risk suicide or substance use disorder in 12 months from MINI other untreated sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome) current diagnosis of Huntington's or Parkinson's disease current treatment for hyperthyroidism currently undergoing chemotherapy presence of asthma or respiratory concerns with night treatment chronic pain treated with opioids epilepsy inability to provide informed consent Not concurrently enrolled in any other intervention or educational study targeting sleep.
Facility Information:
Facility Name
University Of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment

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