Couples Health Aging, Rhythms and Sleep Study

NCT05952284 | Active Not Recruiting

• 1 other identifier: IRB_00158095
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease and related dementias (ADRD), including mild cognitive impairment (MCI), are becoming among the most prevalent causes of disability, death and healthcare costs worldwide. Sleep and circadian rhythm disturbances are common among individuals with MCI as well as their spouses/ partners and may increase risk of the development of ADRD in both patients and partners. This is the first study to systematically investigate sleep as a shared health behavior within couples in which one member has MCI, and the degree to which sleep and circadian disturbances impact both partners health and well-being, including cognitive decline and risk for ADRD.

Conditions

Aging; Memory Loss

Keywords

aging; memory; sleep; circadian rhythms

Outcome Measures

Primary Outcomes (2)

• Digit symbol: daily score

  This is a daily measure of attention and processing speed collected via smartphone. Participants will have 5 minutes to complete the items. In this measure, participants match each symbol presented to a number. The goal of the test is to complete the most items in the time allotted.

  This study will evaluate day to day change in digit symbol performance over 10 days.

• Memory: daily score

  In this measure, participants will have the opportunity to learn a set of 18 words (30 seconds). These words will be present later in the assessment and participants are asked to recognize whether they are on the list.

  This study will evaluate day to day change in digit symbol performance over 10 days.

Secondary Outcomes (1)

• Cogntive function: RBANS total score

  We will evaluate change from baseline to two years

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be married or cohabiting couples recruited from community locations in the United States who meet the study criteria.

You may qualify if:

• Married or partnered in a romantic relationship, cohabiting for at least two years
• age \>50
• smartphone user
• one partner meets criteria for cognitive impairment without severe impairment in daytime dysfunction according to telephone screening, while other partner must not meet this criteria for impairment.

You may not qualify if:

• Unstable or severe medical or psychiatric conditions that would interfere with study participation (including but not limited to current cancer treatment, psychosis, history of major stroke, head injury with loss of consciousness \>30 min, other neurologic/systemic illness that may affect cognition, alcohol or other substance abuse)
• current use of antipsychotic or anticonvulsant medications
• inadequate vision, hearing, or dexterity to participate in the assessment
• night shift work \>1x per month (defined as beginning work after 9:00 pm or work in the overnight hours \[12:00 am-5:00 am\])

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD, MPH

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 19, 2023
• Study Start: September 14, 2023
• Primary Completion: July 21, 2025
• Study Completion (Estimated): July 21, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)