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

NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment

This study is testing if a new memory support program can help older adults with sleep problems feel better and remember things more clearly when combined with a standard sleep treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University of California, Berkeley (Academic / other)
• Locations: 1 site (Berkeley, California)
• Trial ID: NCT05986604 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 and older who experience sleep or circadian disturbances and have a mobility impairment.

Not a fit: Patients with severe untreated sleep disorders or cognitive impairments that prevent them from following treatment protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the quality of life and cognitive function for older adults suffering from sleep and memory issues.

How similar studies have performed: Other studies have shown promise in using cognitive interventions to improve sleep and memory, suggesting that this approach may yield beneficial results.

Eligibility criteria

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 this trial is running

Berkeley, California

• 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

Conditions Sleep Disorder; Circadian Dysregulation; Memory Impairment