Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) (SASinTx)
Primary Purpose
Obstructive Sleep Apnea, Overhydration, End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Renal transplantation
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring polysomnography, bioimpedance, leg fluid shift, neck circumference, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Sleep Disorders, Apnea, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency, Dyssomnias
Eligibility 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
Sites / Locations
- Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted
Outcomes
Primary Outcome Measures
Reduction of the obstructive sleep apnea severity
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
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
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)
Change in the severity of the periodic limb movement disorder (PLMD)
Change in the severity of central sleep apnea
Change in the severity of central sleep apnea
Full Information
NCT ID
NCT02020642
First Posted
December 19, 2013
Last Updated
August 13, 2018
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02020642
Brief Title
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
Acronym
SASinTx
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Overhydration, End Stage Renal Disease, Renal Transplantation
Keywords
polysomnography, bioimpedance, leg fluid shift, neck circumference, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Sleep Disorders, Apnea, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Renal Insufficiency, Dyssomnias
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted
Intervention Type
Procedure
Intervention Name(s)
Renal transplantation
Intervention Description
Renal transplantation from cadaveric or live donor
Primary Outcome Measure Information:
Title
Reduction of the obstructive sleep apnea severity
Description
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation
Time Frame
six months after renal transplantation
Secondary Outcome Measure Information:
Title
Reduction in nocturnal leg fluid volume shift between the legs and the neck
Description
Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after renal transplantation
Time Frame
six months after renal transplantation
Title
Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
Description
Relationship between overhydration (measured by bioimpedance), 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
Title
Change in the severity of the periodic limb movement disorder (PLMD)
Description
Change in the severity of the periodic limb movement disorder (PLMD)
Time Frame
six months after renal transplantation
Title
Change in the severity of central sleep apnea
Description
Change in the severity of central sleep apnea
Time Frame
six months after renal transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rapahël Heinzer, MD
Organizational Affiliation
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Ogna, MD
Organizational Affiliation
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valentina Forni Ogna, MD
Organizational Affiliation
Service de Néphrologie et Hypertension - Centre Hospitalier Universitaire Vaudois (CHUV)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
31912961
Citation
Forni Ogna V, Ogna A, Haba-Rubio J, Nowak G, Venetz JP, Golshayan D, Matter M, Burnier M, Pascual M, Heinzer R. Impact of kidney transplantation on sleep apnea severity: A prospective polysomnographic study. Am J Transplant. 2020 Jun;20(6):1659-1667. doi: 10.1111/ajt.15771. Epub 2020 Jan 21.
Results Reference
derived
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Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
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