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Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients (SASinHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Ogna, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01860209
First received: May 18, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.


Condition Intervention
Obstructive Sleep Apnea
Overhydration
End Stage Renal Disease
Procedure: Hemodialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Reduction of the obstructive sleep apnea severity [ Time Frame: two nights (before and after an ambulatory hemodialysis session) ] [ Designated as safety issue: No ]
    Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session


Secondary Outcome Measures:
  • Reduction in nocturnal leg fluid volume shift between the legs and the neck [ Time Frame: two nights (before and after an ambulatory hemodialysis session) ] [ Designated as safety issue: No ]
    Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session

  • relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome [ Time Frame: one night ] [ Designated as safety issue: No ]
    relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome

  • severity of the periodic limb movement disorder (PLMD) [ Time Frame: two nights (before and after one hemodialysis session) ] [ Designated as safety issue: No ]
    severity of the periodic limb movement disorder (PLMD)

  • severity of central sleep apnea syndrome [ Time Frame: two nights (before and after one hemodialysis session) ] [ Designated as safety issue: No ]
    severity of central sleep apnea syndrome


Enrollment: 20
Study Start Date: March 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night
Procedure: Hemodialysis
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
Experimental: Group B
the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night
Procedure: Hemodialysis
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860209

Locations
Switzerland
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Raphael Heinzer, MD Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Adam Ogna, Centre d'Investigation et Recherche sur le Sommeil (CIRS), Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01860209     History of Changes
Other Study ID Numbers: CIRS-SASinHD
Study First Received: May 18, 2013
Last Updated: December 19, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
obstructive sleep apnea
overhydration
end stage renal disease
intermittent ambulatory hemodialysis
polysomnography
bioimpedance
leg fluid shift
neck circumference

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Intrinsic
Kidney Diseases
Kidney Failure, Chronic
Dyssomnias
Nervous System Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014