- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Vaud
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Lausanne, Vaud, Suisse, 1011
- Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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)
|
|
Expérimental: Group B
the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night
|
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction of the obstructive sleep apnea severity
Délai: two nights (before and after an ambulatory hemodialysis session)
|
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session
|
two nights (before and after an ambulatory hemodialysis session)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction in nocturnal leg fluid volume shift between the legs and the neck
Délai: two nights (before and after an ambulatory hemodialysis session)
|
Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session
|
two nights (before and after an ambulatory hemodialysis session)
|
|
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
Délai: one night
|
relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
|
one night
|
|
severity of the periodic limb movement disorder (PLMD)
Délai: two nights (before and after one hemodialysis session)
|
severity of the periodic limb movement disorder (PLMD)
|
two nights (before and after one hemodialysis session)
|
|
severity of central sleep apnea syndrome
Délai: two nights (before and after one hemodialysis session)
|
severity of central sleep apnea syndrome
|
two nights (before and after one hemodialysis session)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Raphael Heinzer, MD, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies des voies respiratoires
- Troubles respiratoires
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Maladies urologiques
- Insuffisance rénale
- Signes et symptômes respiratoires
- Insuffisance rénale chronique
- Syndromes d'apnée du sommeil
- Apnée du sommeil, obstructive
- Maladies rénales
- Apnée
- Insuffisance rénale chronique
Autres numéros d'identification d'étude
- CIRS-SASinHD
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