Obstructive Sleep Apnea Clinical Trial
— SASinTxOfficial 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
NCT number | NCT02020642 |
Other study ID # | CIRS-SASinTx |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | December 2017 |
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the obstructive sleep apnea severity | Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation | six months after renal transplantation | |
Secondary | 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 | six months after renal transplantation | |
Secondary | 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 | at baseline and six months after renal transplantation | |
Secondary | Change in the severity of the periodic limb movement disorder (PLMD) | Change in the severity of the periodic limb movement disorder (PLMD) | six months after renal transplantation | |
Secondary | Change in the severity of central sleep apnea | Change in the severity of central sleep apnea | six months after renal transplantation |
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