Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia.
- Who it may be relevant to
- Registry conditions: Sleep Disturbance, Dementia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.
There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.
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]
- Change in Sleep Efficiency [Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention]
- Change in in Sleep Onset Latency [Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention]
- Change in Wake After Sleep Onset [Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention]
- Adherence with Study Interventions (feasibility) [Time frame: weekly during the intervention period up to 3 months post-intervention]
- Satisfaction with intervention components [Time frame: 1 week post-intervention]
Secondary outcome measures (2)
- Change in depression [Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention]
- Change in the Quality of Life [Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention]
Eligibility criteria
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
- Prisoners
- Individuals who are not able to clearly understand English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Emory Healthcare System — Atlanta
Identifiers
NCT: NCT06250725 · STUDY00006711 · 5K23AG070378-03 · 2025P009764