Recruiting

Online sleep therapy to protect thinking skills in older adults

Plain-English translation of NCT05565833 on ClinicalTrials.gov ↗ · Source last updated May 2024 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing an internet-based cognitive behavioral therapy for insomnia (CBT-I) called SHUTi OASIS to see if improving sleep can help slow down thinking and memory problems in older adults with mild cognitive impairment. Sleep problems are common in people with early cognitive changes, and researchers want to know whether treating insomnia might also protect brain health. You'll use the program online from home for 9 weeks, then be followed for up to 2 years.

Poor sleep and cognitive decline often go hand-in-hand in older adults, but it's unclear whether fixing sleep problems can help preserve memory and thinking skills. This study aims to find out if this medication-free online approach could be a simple way to protect brain health.

Do you qualify?

You likely qualify if…

you are 65 years or older
you have been struggling with sleep problems (trouble falling asleep or staying asleep) for at least three months that bother you or affect your daily life
you have mild cognitive changes confirmed by study testing
you have internet access and can read and speak English
you are a U.S. resident willing to complete online activities and assessments over two years

You likely don't qualify if…

you are currently receiving therapy or treatment for sleep problems or have started psychiatric treatment in the past three months
you have Parkinson's disease, Huntington's disease, untreated severe sleep apnea, or other serious untreated sleep disorders
you have a history of bipolar disorder, psychosis, or are at moderate-to-high risk of suicide
you have had recent chemotherapy, brain injury, tumor, or infection that you haven't fully recovered from
you have had alcohol or drug misuse problems in the past year

What participation looks like

You'll start with online testing and two weeks of sleep tracking to establish a baseline. Then you'll be randomly assigned to either the SHUTi OASIS sleep therapy program or a patient education website, both accessed online. The active program lasts 9 weeks and involves spending 1–2 hours completing daily sleep diaries and interactive lessons about sleep behaviors and thoughts. After week 9, you'll repeat the cognitive tests and questionnaires, then continue with follow-up assessments at 6, 12, 18, and 24 months—all completed online from home.

AI-generated summary from trial data · Jun 4, 2026 · Not medical advice

Trial locations(1 site)

United States

University of Virginia, Charlottesville, Virginia