AgingCHARMSNCT05952284
Couples Health Aging, Rhythms and Sleep Study
An observational study of Aging and Memory Loss, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Memory Loss
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 21 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be married or cohabiting couples recruited from community locations in the United States who meet the study criteria.
Who may be able to join
- 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.
Who cannot join
- 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])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Couples Health Aging, Rhythms and Sleep Study (CHARMS Study)
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.
Read the detailed description
Individuals with mild cognitive impairment (MCI) demonstrate cognitive decline without major functional impairment but also experience a 7-fold increased risk for developing Alzheimer's disease, a leading cause of poorer quality of life (QOL), premature mortality, and health care expenditures. Sleep and biobehavioral rhythm disturbances (disruptions in 24h oscillations in physiology and behavior, including rest-activity patterns and mealtimes) are more than twice as common among patients with MCI than cognitively intact older adults. Emerging evidence demonstrates a mechanistic role of sleep and biobehavioral rhythm disturbances in cognitive decline and the development and progression of Alzheimer's disease. Importantly, the consequences of sleep and biobehavioral rhythm disruption in MCI extend beyond the patient, also affecting the spouse/partner, as sleep is a "shared" health behavior for most adults. However, sleep and biobehavioral rhythms are typically considered at the level of the individual.
The overall goal of the study is to investigate sleep and biobehavioral rhythms as fundamental dyadic processes that contribute to the health and cognitive functioning of individuals with MCI or mild AD and their partners. The project will evaluate the daily and longitudinal effects of two dyadic processes in sleep:interdependence (partners' sleep patterns influence on each other) and concordance (i.e., the couples' similarity in rest/activity and social rhythms such as meal timing). The protocol involves a 14-day naturalistic study protocol in order to examine the mechanistic associations between sleep and biobehavioral rhythms and proximal indicators of daytime functioning, within a sample of 170 couples in which one partner evidences cognitive impairment (MCI to mild Alzheimer's disease). During the naturalistic study protocol, measures will capture sleep and biobehavioral rhythms via objective (actigraphy) measures of sleep and circadian rest-activity rhythms and daily social rhythms, respectively. Also, measures include daily assessments of mood and relationship quality and an an innovative smartphone cognitive assessment that has been validated to measure cognitive function in daily life. The longitudinal assessment will include comprehensive neuropsychological assessments at baseline and again at two-year follow-up to examine how sleep and biobehavioral rhythm disruptions at baseline predict cognitive decline over 2 years in both partners.
Results of study will advance the understanding of the daily and longitudinal relationships between the individual and couple-level processes in sleep and biobehavioral rhythms that influence the progression of cognitive decline in a population at increased risk for developing Alzheimer's disease.
- Conditions
- Aging, Memory Loss
- Keywords
- aging, memory, sleep, circadian rhythms
- Medical subject headings
- Memory Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 administer a standardized test battery called the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). This test takes approximately 30 min and measures the main domains of cognitive function, including immediate memory, visuospatial/construction, language, attention, delayed memory and effort
Measured: We will evaluate change from baseline to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start14 Sep 2023
- Primary completion21 Jul 2025
- Study completion21 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952284
- Sponsor's protocol ID
- IRB_00158095
- Acronym
- CHARMS
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Health Aging, Rhythms and Sleep Study (CHARMS Study)
- ClinicalTrials.gov ID
- NCT05952284
- Acronym / sponsor ID
- CHARMS / IRB_00158095
- Conditions
- Aging, Memory Loss
- Keywords
- aging, memory, sleep, circadian rhythms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2027 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with mild cognitive impairment (MCI) demonstrate cognitive decline without major functional impairment but also experience a 7-fold increased risk for developing Alzheimer's disease, a leading cause of poorer quality of life (QOL), premature mortality, and health care expenditures. Sleep and biobehavioral rhythm disturbances (disruptions in 24h oscillations in physiology and behavior, including rest-activity patterns and mealtimes) are more than twice as common among patients with MCI than cognitively intact older adults. Emerging evidence demonstrates a mechanistic role of sleep and biobehavioral rhythm disturbances in cognitive decline and the development and progression of Alzheimer's disease. Importantly, the consequences of sleep and biobehavioral rhythm disruption in MCI extend beyond the patient, also affecting the spouse/partner, as sleep is a "shared" health behavior for most adults. However, sleep and biobehavioral rhythms are typically considered at the level of the individual.
The overall goal of the study is to investigate sleep and biobehavioral rhythms as fundamental dyadic processes that contribute to the health and cognitive functioning of individuals with MCI or mild AD and their partners. The project will evaluate the daily and longitudinal effects of two dyadic processes in sleep:interdependence (partners' sleep patterns influence on each other) and concordance (i.e., the couples' similarity in rest/activity and social rhythms such as meal timing). The protocol involves a 14-day naturalistic study protocol in order to examine the mechanistic associations between sleep and biobehavioral rhythms and proximal indicators of daytime functioning, within a sample of 170 couples in which one partner evidences cognitive impairment (MCI to mild Alzheimer's disease). During the naturalistic study protocol, measures will capture sleep and biobehavioral rhythms via objective (actigraphy) measures of sleep and circadian rest-activity rhythms and daily social rhythms, respectively. Also, measures include daily assessments of mood and relationship quality and an an innovative smartphone cognitive assessment that has been validated to measure cognitive function in daily life. The longitudinal assessment will include comprehensive neuropsychological assessments at baseline and again at two-year follow-up to examine how sleep and biobehavioral rhythm disruptions at baseline predict cognitive decline over 2 years in both partners.
Results of study will advance the understanding of the daily and longitudinal relationships between the individual and couple-level processes in sleep and biobehavioral rhythms that influence the progression of cognitive decline in a population at increased risk for developing Alzheimer's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be married or cohabiting couples recruited from community locations in the United States who meet the study criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digit symbol: daily score
Time frame: This study will evaluate day to day change in digit symbol performance over 10 days.
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.
Memory: daily score
Time frame: This study will evaluate day to day change in digit symbol performance over 10 days.
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.
1 secondary outcome
Cogntive function: RBANS total score
Time frame: We will evaluate change from baseline to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Data available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Memory Loss, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit symbol: daily score (time frame: This study will evaluate day to day change in digit symbol performance over 10 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.