Improving memory and well-being in older adults with sleep issues

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 study aims to evaluate the effectiveness of a novel Memory Support Intervention (MSI) combined with a transdiagnostic treatment for sleep and circadian dysfunction in adults aged 50 and older. Participants will be randomly assigned to receive either the combined intervention or the transdiagnostic treatment alone, with assessments conducted at baseline, post-treatment, and at 6- and 12-month follow-ups. The study seeks to determine if the addition of MSI enhances sleep quality, daytime functioning, well-being, and memory retention compared to the standard treatment. The research will involve 178 participants over a five-year period, focusing on improving health outcomes for older adults experiencing sleep disturbances.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Aged 50 years and older;
2. English language fluency;
3. Experiencing a mobility impairment;
4. Low income;
5. Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions.
6. 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
7. Able/willing to give informed consent.

Exclusion criteria:

1. Severe untreated sleep disordered breathing (AHI\>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale \>10);
2. Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
3. Homelessness;
4. Night shift work \>2 nights per week in the past 3 months;
5. Substance abuse/dependence only if it makes participation in the study unfeasible;
6. Suicide risk sufficient to preclude treatment on an outpatient basis.

Where it's running

• University of California, Berkeley
  Berkeley, California, United States Recruiting

Study contacts

• Principal investigator: Allison Harvey, PhD — University of California, Berkeley
• Study coordinator: Allison Harvey, PhD
• Email: aharvey@berkeley.edu
• Phone: 5106427138

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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.