Internet-based therapy for insomnia and cognitive health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial evaluates the effects of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) on sleep and cognitive health in individuals with mild cognitive impairment. Participants with insomnia will be recruited and randomized to receive either the CBT-I intervention or patient education. The study will assess various outcomes, including sleep quality, daytime functioning, and cognitive status through online assessments and sleep diaries over a period of 24 months. The goal is to determine the effectiveness of the CBT-I intervention in improving both sleep and cognitive function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 65 years of age.
* Able to speak and read English, and is a US resident.
* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
* Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
* The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months.
* Cognitive impairment through study assessment.
* Stable medication regimen unless medication is known to cause insomnia

Exclusion Criteria:

* Current psychological treatment for insomnia
* Initiation of psychological or psychiatric treatment within the past three months
* 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
* Not recovered from a brain tumor, injury, or infection
* Epilepsy without stable treatment for at least 3 months
* Irregular sleep schedule
* Use of stimulating medications after 5pm or taken for less than 3 months
* Psychotic or bipolar disorder
* Moderate to high risk of suicide
* Alcohol or drug abuse within the past year
* Other untreated sleep disorders (e.g., obstructive sleep apnea)
* Study screen for severe depression

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Meghan K Mattos, PhD, RN, CNL — University of Virginia
• Study coordinator: Meghan K Mattos, PhD, RN, CNL
• Email: ms2bv@virginia.edu
• Phone: 434-243-3936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.