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

NCT01860209 | Completed DMC

• 1 other identifier: CIRS-SASinHD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Overhydration; End Stage Renal Disease

Keywords

obstructive sleep apnea; overhydration; end stage renal disease; intermittent ambulatory hemodialysis; polysomnography; bioimpedance; leg fluid shift; neck circumference

Outcome Measures

Primary Outcomes (1)

• Reduction of the obstructive sleep apnea severity

  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)

Secondary Outcomes (4)

• Reduction in nocturnal leg fluid volume shift between the legs and the neck

  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

  one night

• severity of the periodic limb movement disorder (PLMD)

  two nights (before and after one hemodialysis session)

• severity of central sleep apnea syndrome

  two nights (before and after one hemodialysis session)

Study Arms (2)

Group A

EXPERIMENTAL

the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night

Procedure: Hemodialysis

Group B

EXPERIMENTAL

the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night

Procedure: Hemodialysis

Interventions

Hemodialysis PROCEDURE

Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unstable congestive heart failure
• pace-maker
• active psychiatric disease
• amputation of the lower limbs, proximal to the ankle

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Water Intoxication; Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Raphael Heinzer, MD

  Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Centre d'Investigation et Recherche sur le Sommeil (CIRS)

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: May 22, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CH (1)