Идёт набор NCT06250725

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

Без фазы С лечением Sleep Disturbance Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cognitive Behavioral Therapy for Insomnia.
Кому может быть актуально: Состояния в реестре: Sleep Disturbance, Dementia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Change in insomnia [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]
Change in Sleep Efficiency [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]
Change in in Sleep Onset Latency [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]
Change in Wake After Sleep Onset [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]
Adherence with Study Interventions (feasibility) [Срок оценки: weekly during the intervention period up to 3 months post-intervention]
Satisfaction with intervention components [Срок оценки: 1 week post-intervention]

Вторичные конечные точки (2)

Change in depression [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]
Change in the Quality of Life [Срок оценки: Baseline, 1-week post-intervention, and 3 months post-intervention]

Критерии участия

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