Trial record 12 of 431 for:    Open Studies | kidney transplantation

Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Information provided by (Responsible Party):
Adam Ogna, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT02020642
First received: December 19, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. 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
Renal Transplantation
Procedure: Renal transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Prospective Interventional Study Investigating the Effect of Renal Transplantation on Obstructive Sleep Apnea 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: six months after renal transplantation ] [ Designated as safety issue: No ]
    Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation


Secondary Outcome Measures:
  • Reduction in nocturnal leg fluid volume shift between the legs and the neck [ Time Frame: six months after renal transplantation ] [ Designated as safety issue: No ]
    Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after renal transplantation

  • Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea [ Time Frame: at baseline and six months after renal transplantation ] [ 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

  • Change in the severity of the periodic limb movement disorder (PLMD) [ Time Frame: six months after renal transplantation ] [ Designated as safety issue: No ]
    Change in the severity of the periodic limb movement disorder (PLMD)

  • Change in the severity of central sleep apnea [ Time Frame: six months after renal transplantation ] [ Designated as safety issue: No ]
    Change in the severity of central sleep apnea


Estimated Enrollment: 36
Study Start Date: October 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation
Procedure: Renal transplantation
Renal transplantation from cadaveric or live donor
No Intervention: Control Group
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted

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 fluid overload, including chronic renal failure.

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

The severity of obstructive sleep apnea is measured by two attended polysomnographies, a baseline PSG performed before and a follow-up PSG performed 6 month after renal transplantation. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who are not already transplanted 6 months after the baseline PSG will be re-assessed and will be analyzed as control group.

  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, with an apnea-hypopnea index (AHI) ≥ 15/h
  • age ≥ 18 years
  • patient with end stage renal disease on waiting list for a renal transplantation (cadaveric or live donor).

Exclusion Criteria:

  • unstable congestive heart failure
  • 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: NCT02020642

Contacts
Contact: Raphaël Heinzer, MD +41 21 314 67 48 raphael.heinzer@chuv.ch
Contact: Adam Ogna, MD +41 21 314 67 48 adam.ogna@chuv.ch

Locations
Switzerland
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Raphaël Heinzer, MD    +41 21 314 67 48    raphael.heinzer@chuv.ch   
Contact: Adam Ogna, MD    +41 21 314 67 48    adam.ogna@chuv.ch   
Principal Investigator: Adam Ogna, MD         
Principal Investigator: Valentina Forni Ogna, MD         
Principal Investigator: Raphaël Heinzer, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Rapahël Heinzer, MD Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Principal Investigator: Adam Ogna, MD Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Principal Investigator: Valentina Forni Ogna, MD Service de Néphrologie et Hypertension - Centre Hospitalier Universitaire Vaudois (CHUV)
  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: NCT02020642     History of Changes
Other Study ID Numbers: CIRS-SASinTx
Study First Received: December 19, 2013
Last Updated: December 26, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
polysomnography
bioimpedance
leg fluid shift
neck circumference
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Apnea
Dyssomnias

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

ClinicalTrials.gov processed this record on August 21, 2014