Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adherence with Study Interventions (feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •PLwCI: Moderate to severe cognitive impairment
- •Individuals who are not yet adults
- •Pregnant women
- •Prisoners
- •Individuals who are not able to clearly understand English.
研究组 & 干预措施
Cognitive Behavioral Therapy for Insomnia (CBTi)
Participant dyads will receive CBTi via videoconferencing sessions
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Adherence with Study Interventions (feasibility)
时间窗: 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.
Change in insomnia
时间窗: 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
时间窗: 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.
Satisfaction with intervention components
时间窗: 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.
Change in in Sleep Onset Latency
时间窗: 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
时间窗: 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.
次要结局
- Change in depression(Baseline, 1-week post-intervention, and 3 months post-intervention)
- Change in the Quality of Life(Baseline, 1-week post-intervention, and 3 months post-intervention)
研究者
Glenna Brewster
Assistant Professor
Emory University