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NCT Number: NCT06250725

Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners

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.

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Key information

Conditions

Sleep Disturbance Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

Rashidat Ayantunji

CONTACT

[email protected]

404-727-9953

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Other names: CBTi

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Change in depression

    Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention

    Depression will be measured using the Center for Epidemiologic Studies Depression scale. The Center for Epidemiologic Studies Depression scale has 20 questions. The 20 answers are added up to get a total score between 0 and 60.

    Total score categories:

    16 or greater = Clinically significant depressive symptoms

  2. Change in the Quality of Life

    Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention

    Quality of Life will be measured using the research and development (RAND) Medical Outcomes short form (SF)-36. The insomnia severity index has 36 questions which have subscales that total 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Glenna S Brewster, PhD, RN, FNP

CONTACT

[email protected]

(404) 712-9164

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: SLEEPMATE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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