NCT02073344

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

7.7 years

First QC Date

February 25, 2014

Last Update Submit

August 3, 2020

Conditions

Obstructive Sleep ApneaEnd Stage Renal Disease

Keywords

obstructive sleep apneaoverhydrationend stage renal diseaserenal transplantationpolysomnographybioimpedanceleg fluid shiftneck circumference

Outcome Measures

Primary Outcomes (1)

  • obstructive sleep apnea severity

    Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy

    six months (before and after beginning of a renal replacement therapy)

Secondary Outcomes (4)

  • nocturnal leg fluid volume shift

    six months (before and 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

    one night

  • periodic limb movement disorder (PLMD)

    six months (before and after beginning of a renal replacement therapy)

  • severity of central sleep apnea syndrome

    six months (before and after renal beginning of a renal replacement therapy)

Study Arms (2)

Intevention group

EXPERIMENTAL

A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG 6 months after the beginning of a renal replacement therapy

Procedure: Renal replacement therapy

Control group

EXPERIMENTAL

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

Other: no intervention

Interventions

Renal replacement therapyPROCEDURE

intermittent hemodialysis or peritoneal dialysis

Intevention group
no interventionOTHER

no renal replacement therapy

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 without renal replacement therapy.

You may not qualify if:

  • unstable congestive heart failure
  • active psychiatric disease
  • amputation of the lower limbs, proximal to the ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveKidney Failure, ChronicWater Intoxication

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Raphaël 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

    Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
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

February 25, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

CH(1)