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

NCT02020642 | Completed DMC

• 1 other identifier: CIRS-SASinTx
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  six months after renal transplantation

• Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea

  at baseline and six months after renal transplantation

• Change in the severity of the periodic limb movement disorder (PLMD)

  six months after renal transplantation

• Change in the severity of central sleep apnea

  six months after renal transplantation

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

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 transplanted

Interventions

Renal transplantation PROCEDURE

Renal transplantation from cadaveric or live donor

Intervention Group

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, 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).

You may not qualify if:

• unstable congestive heart failure
• 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

Related Publications (1)

• 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.

  PMID: 31912961 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Water Intoxication; Kidney Failure, Chronic; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Apnea; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Dyssomnias

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders; 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; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• 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: December 19, 2013
• First Posted: December 25, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

CH (1)