Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinHD_005)
Primary Purpose
Obstructive Sleep Apnea, End Stage Renal Disease
Status
Suspended
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Renal replacement therapy
no intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, overhydration, end stage renal disease, renal transplantation, polysomnography, bioimpedance, leg fluid shift, neck circumference
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 without renal replacement therapy.
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
Experimental
Arm Label
Intevention group
Control group
Arm Description
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy
No intervention A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already on renal replacement therapy
Outcomes
Primary Outcome Measures
obstructive sleep apnea severity
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy
Secondary Outcome Measures
nocturnal leg fluid volume shift
Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after beginning of a renal replacement therapy
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
periodic limb movement disorder (PLMD)
severity of central sleep apnea syndrome
Full Information
NCT ID
NCT02073344
First Posted
February 25, 2014
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02073344
Brief Title
Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients
Acronym
SASinHD_005
Official Title
Prospective Interventional Study Investigating the Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea and Its Correlation With Overhydration, in End Stage Renal Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Suspended
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of beginning a renal replacement therapy 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
The prevalence of obstructive sleep apnea increases with progressing renal insufficiency. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. We suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure.
The beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population.
The purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift.
The severity of obstructive sleep apnea is measured by two attended polysomnographies (PSG), a baseline PSG performed before and a follow-up PSG performed 6 month after beginning of a renal replacement therapy. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who have not yet begun a renal replacement therapy 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, End Stage Renal Disease
Keywords
obstructive sleep apnea, overhydration, end stage renal disease, renal transplantation, polysomnography, bioimpedance, leg fluid shift, neck circumference
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intevention group
Arm Type
Experimental
Arm Description
A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy
Arm Title
Control group
Arm Type
Experimental
Arm Description
No intervention A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already on renal replacement therapy
Intervention Type
Procedure
Intervention Name(s)
Renal replacement therapy
Intervention Description
intermittent hemodialysis or peritoneal dialysis
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
no renal replacement therapy
Primary Outcome Measure Information:
Title
obstructive sleep apnea severity
Description
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy
Time Frame
six months (before and after beginning of a renal replacement therapy)
Secondary Outcome Measure Information:
Title
nocturnal leg fluid volume shift
Description
Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference six months after beginning of a renal replacement therapy
Time Frame
six months (before and after beginning of a renal replacement therapy)
Title
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea
Time Frame
one night
Title
periodic limb movement disorder (PLMD)
Time Frame
six months (before and after beginning of a renal replacement therapy)
Title
severity of central sleep apnea syndrome
Time Frame
six months (before and after renal beginning of a renal replacement therapy)
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 without renal replacement therapy.
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
Raphaël 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
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - 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
Learn more about this trial
Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea in End Stage Renal Disease Patients
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