- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01860209
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients (SASinHD)
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Obstructive sleep disordered breathing is more prevalent in end stage kidney disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are poorly understood. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft and the severity of obstructive sleep apnea. This mechanism was demonstrated in otherwise healthy subjects, in heart failure patients, and in patients with venous insufficiency. We thus suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with hypervolemia, including chronic renal failure.
The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.
The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vaud
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Lausanne, Vaud, Suiza, 1011
- Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
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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:
- moderate to severe obstructive sleep apnea syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
- age ≥ 18 years
- patient with end stage renal disease on chronic intermittent hemodialysis
Exclusion criteria:
- unstable congestive heart failure
- pace-maker
- active psychiatric disease
- amputation of the lower limbs, proximal to the ankle
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A
the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night
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Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
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Experimental: Group B
the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night
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Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction of the obstructive sleep apnea severity
Periodo de tiempo: two nights (before and after an ambulatory hemodialysis session)
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Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session
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two nights (before and after an ambulatory hemodialysis session)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction in nocturnal leg fluid volume shift between the legs and the neck
Periodo de tiempo: two nights (before and after an ambulatory hemodialysis session)
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Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session
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two nights (before and after an ambulatory hemodialysis session)
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|
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
Periodo de tiempo: one night
|
relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
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one night
|
|
severity of the periodic limb movement disorder (PLMD)
Periodo de tiempo: two nights (before and after one hemodialysis session)
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severity of the periodic limb movement disorder (PLMD)
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two nights (before and after one hemodialysis session)
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|
severity of central sleep apnea syndrome
Periodo de tiempo: two nights (before and after one hemodialysis session)
|
severity of central sleep apnea syndrome
|
two nights (before and after one hemodialysis session)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Raphael Heinzer, MD, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
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
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Enfermedades urológicas
- Insuficiencia renal
- Signos y Síntomas Respiratorios
- Insuficiencia Renal Crónica
- Síndromes de apnea del sueño
- Apnea del Sueño Obstructiva
- Enfermedades Renales
- Apnea
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- CIRS-SASinHD
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