Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment
Completed · Not applicable
Conditions studied: Mild Cognitive Impairment, Cognitive Impairment, Insomnia
In brief
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.
Key facts
- Study ID
- NCT04382365
- Run by
- University of Virginia
- People needed
- 12
- Starts
- 2018-12-05
- Expected to finish
- 2020-05-28
- Last updated by the study team
- 2021-04-27
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
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.
Where it is running
- University Of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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