- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01550172
Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33612
- University of South Florida
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Primary caregiver for a relative who has been diagnosed by a physician with dementia or Alzheimer's disease.
- Persons with dementia sleep in the same location each night.
- Caregiver provides care for persons with dementia with nighttime activity that occurs at least one night/week.
- Caregiver meets the standard criteria for Insomnia.
- Caregiver sleep problems affect daytime functioning.
- If caregiver uses sleep medication, dose stable for 6 months.
- Caregiver Telephone Interview for Cognitive Status Score > 25.
- Caregiver does not require assistive devices to walk in the home at night.
Exclusion Criteria:
- Caregiver receives respite care at night the majority of the time.
- Caregiver has diagnosed sleep disorder.
- Caregiver uses CPAP at night
- Caregiver has chronic illness that requires frequent, weekly treatment/assessment by a healthcare provider.
- Current use of anticoagulant medication by the caregiver.
- Caregiver Sleep Apnea-Hypopnea Index (AHI) score > 10 or > 15 if pulse oximetry ≥ 88%.
- Caregiver shows evidence of Restless Leg Syndrome per the Cambridge-Hopkins Restless Leg Syndrome Questionnaire.
- Montreal Cognitive Assessment (MOCA) score < 26.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Sleep Behavioral Therapy A and NHMS
Participants in this arm receive behavioral therapy A for insomnia and the night home monitoring system.
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The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night. Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments. |
Comparador activo: Sleep Behavioral Therapy B and NHMS
Participants in this arm receive sleep behavioral therapy B and the night home monitoring system.
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The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night. Sleep behavioral therapy B uses primarily behavioral adjustments. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Wake Time (TWT)
Periodo de tiempo: Week 27-28
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Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability. Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of TWT. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating. |
Week 27-28
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Sleep Efficiency (SE)
Periodo de tiempo: Week 27-28
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Actigraphy, using the Actiwatch2, will be used to measure objective sleep; We will collect data for 14-day periods using a 30-second epoch length to accurately capture night-to-night variability. Subjects will also complete a sleep diary for each day of actigraphic data collection, which will provide subjective sleep values of SE. Data collected include bedtime, sleep start, number awakenings, minutes awake during night, wake time, out-of-bed time, minutes spent napping the previous day, and a sleep quality rating. |
Week 27-28
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Nighttime Injuries
Periodo de tiempo: Week 27-28
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The Caregiver will be asked about any PWD injuries that occurred since the last data collection point.
Injuries will be coded according to the American National Standards method of recording injuries.
The following data are collected: nature of injury; part of the body affected; object, substance, exposure, or bodily motion that caused the injury; event that directly resulted in the injury; and time and place of the injury's occurrence.
An injury will be considered nighttime if the caregiver reported being asleep at the time the injury occurred.
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Week 27-28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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D-Dimer Levels
Periodo de tiempo: Week 27
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D-Dimer is a marker of coagulation activation and has been associated with coronary events.
It has also been inversely associated with wake after sleep onset as well as poor sleep quality and low sleep efficiency.
D-dimer is a byproduct of fibrinolysis which remains after a blood clot has been degraded.
It consists of two cross linked fragments of fibrinogen.
Elevated levels of D-dimer are a marker of thrombosis, as it might occur along atherosclerotic plaques in coronary blood vessels.
D-dimer will be measured by monoclonal sandwich ELISA, which measures in the 3.9 - 250 ng/ml range.
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Week 27
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Tissue Plasminogen Activator Levels
Periodo de tiempo: Week 27
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Tissue Plasminogen Activator is an endothelial lining protein that catalyzes the conversion of plasminogen into plasmin, which is responsible for the degradation of fibrin into soluble degradation products.
Caregivers of PWD showed higher levels of TPA.
A meta-analysis of cardiovascular disease risk and TPA indicated that levels greater than 13.5 ng/ml increased CVD risk by 50%.
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Week 27
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C-reactive Protein (CRP) Levels
Periodo de tiempo: Week 27
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C-reactive protein (CRP) is a non-specific marker of inflammation shown in many studies to be elevated in AD caregivers and to be associated with poor sleep.
High sensitivity CRP levels are consistently and independently associated with increased risk of cardiovascular events.
HS-CRP will be measured by an ELISA.
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Week 27
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Intercellular Adhesion Molecule-1 (ICAM-1)
Periodo de tiempo: Week 27
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Intercellular adhesion molecule-1 (ICAM-1) is found in leukocytes and endothelium and is involved in adhesion of leukocytes to and through the endothelium.
ICAM-1 is stimulated by the proinflammatory cytokines.
ICAM-1 may participate in atherogenesis by increasing monocyte transmigration into the arterial intima.
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Week 27
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IL-6, and TNFα Levels
Periodo de tiempo: Week 27
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It is becoming apparent that sleep and immunity are strongly related and that impairments in sleep increase these circulating cytokine levels.
Further, caregivers of Alzheimer's patients show both impaired sleep and elevated IL-6 and TNF-α.
Levels of IL-6, IL-1, and TNF-α are partially controlled by sleep, and also regulate sleep and many aspects of the immune response.
IL-6 and TNF-α are central mediators in the inflammatory process by regulating acute phase and coagulation protein, and inflammation plays a central role in the development and instability of atherosclerotic plaques.
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Week 27
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meredeth Rowe, RN, PhD, University of South Florida
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6201111800
- 1R01AG039495-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Sleep Behavioral Therapy A and NHMS
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AIDS Arms Inc.Terminado
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VA Office of Research and DevelopmentRetiradoTrastornos del sueño y la vigilia | Alteración del sueño | Deterioro relacionado con el sueñoEstados Unidos