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

NCT04382365 | Completed

• 1 other identifier: IRB-HSR #20990
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Cognitive Impairment; Insomnia

Outcome Measures

Primary Outcomes (8)

• Increase in Sleep Duration

  Patient generated data on sleep through questionnaires

  Baseline

• Increase in Sleep Duration

  Patient generated data on sleep through questionnaires

  11 weeks

• Impact on Psychological Distress

  Patient generated data on sleep through questionnaires

  Baseline

• Impact on Psychological Distress

  Patient generated data on sleep through questionnaires

  11 weeks

• Impact on Overall Health

  Patient generated data on sleep through questionnaires

  Baseline

• Impact on Overall Health

  Patient generated data on sleep through questionnaires

  11 weeks

• Impact on Sleep Pattern

  Data obtained through wrist actigraphy.

  Baseline

• Impact on Sleep Pattern

  Data obtained through wrist actigraphy.

  11 weeks

Study Arms (1)

Internet-Based Insomnia Intervention

OTHER

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.

Other: Sleep Health Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness

Interventions

Sleep Health Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness OTHER

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.

Internet-Based Insomnia Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University Of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 11, 2020
• Study Start: December 5, 2018
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)