NCT05986604 NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
| NCT ID | NCT05986604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Berkeley |
| Condition | Sleep Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2024-01-04 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2024-01-04 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
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.
Contact & Investigator
Allison Harvey, PhD
PRINCIPAL INVESTIGATOR
University of California, Berkeley
Frequently Asked Questions
Who can join the NCT05986604 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Sleep Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05986604 currently recruiting?
Yes, NCT05986604 is actively recruiting participants. Contact the research team at aharvey@berkeley.edu for enrollment information.
Where is the NCT05986604 trial being conducted?
This trial is being conducted at Berkeley, United States.
Who is sponsoring the NCT05986604 clinical trial?
NCT05986604 is sponsored by University of California, Berkeley. The principal investigator is Allison Harvey, PhD at University of California, Berkeley. The trial plans to enroll 178 participants.