NCT06250725 · Emory University
Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
(SLEEPMATE)
What this study is about
The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
View original scientific description
The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
Interventions
BEHAVIORAL
Cognitive Behavioral Therapy for Insomnia
The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.
Primary outcome measures
Change in insomnia
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Insomnia will be measured using the Insomnia Severity Index. The insomnia severity index ahs seven questions. The seven answers are added up to get a total score. Total score categories: 0-7= No clinically significant insomnia 8-14= Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) 22-28= Clinical insomnia (Severe)
Change in Sleep Efficiency
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep Efficiency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Change in in Sleep Onset Latency
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep onset latency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Change in Wake After Sleep Onset
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Wake after sleep onset will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Adherence with Study Interventions (feasibility)
Time frame: weekly during the intervention period up to 3 months post-intervention
Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation.
Satisfaction with intervention components
Time frame: 1 week post-intervention
Satisfaction with the intervention components will be assessed with the study satisfaction measure questionnaire that has 16 questions type that uses an agree, disagree scale as a range of answer options that go from strongly agree to strongly disagree.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for the PLwCI:
- Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or
- Montreal Cognitive Assessment (MOCA) score between 12 and 24;
- Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
- Have an eligible caregiver;
- Be able to participate in the intervention sessions Inclusion Criteria for Caregivers:
- ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI);
- Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or
- ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months;
- Have difficulty falling asleep or difficulty staying asleep for the last three months or
- Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater
Exclusion criteria
- PLwCI: Moderate to severe cognitive impairment
- Individuals who are not yet adults
- Pregnant women
- Individuals who are not able to clearly understand English.
Where
- Atlanta, Georgia
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations