Obstructive Sleep ApneaSASinTxNCT02020642
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)
A study testing Renal transplantation in people with Obstructive Sleep Apnea and Overhydration, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Overhydration, End Stage Renal Disease
- What is being tested?
- Renal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- unstable congestive heart failure
- active psychiatric disease
- amputation of the lower limbs, proximal to the ankle
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
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
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.
Read the 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.
- Being tested
- 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
- Medical subject headings
- Sleep Apnea, Obstructive, Water Intoxication, Kidney Failure, Chronic, Sleep Apnea Syndromes, Sleep Disorders, Intrinsic, Sleep Wake Disorders, Apnea, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal transplantationProcedure or surgery
Renal transplantation from cadaveric or live donor
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the obstructive sleep apnea severity
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation
Measured: six months after renal transplantation
Secondary outcomes (4)
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
Measured: 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
Measured: at baseline and six months after renal transplantation
Change in the severity of the periodic limb movement disorder (PLMD)
Change in the severity of the periodic limb movement disorder (PLMD)
Measured: six months after renal transplantation
Change in the severity of central sleep apnea
Change in the severity of central sleep apnea
Measured: six months after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Ogna, Centre Hospitalier Universitaire Vaudois
- Investigators
- Rapahël Heinzer, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)Adam Ogna, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)Valentina Forni Ogna, MD, Principal investigator, Service de Néphrologie et Hypertension - Centre Hospitalier Universitaire Vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020642
- Sponsor's protocol ID
- CIRS-SASinTx
- Acronym
- SASinTx
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2013
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31912961
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02020642
- Acronym / sponsor ID
- SASinTx / CIRS-SASinTx
- Keywords
- polysomnography, bioimpedance, leg fluid shift, neck circumference, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disorders, Intrinsic, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Renal transplantationA baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- unstable congestive heart failure
- active psychiatric disease
- amputation of the lower limbs, proximal to the ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal transplantationRenal transplantation from cadaveric or live donor | Procedure or surgery | Intervention Group |
Primary outcome
Reduction of the obstructive sleep apnea severity
Time frame: six months after renal transplantation
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation
4 secondary outcomes
Reduction in nocturnal leg fluid volume shift between the legs and the neck
Time frame: six months after renal transplantation
Relationship between overhydration, 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
Change in the severity of the periodic limb movement disorder (PLMD)
Time frame: six months after renal transplantation
Change in the severity of central sleep apnea
Time frame: six months after renal transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 31912961Forni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rapahël Heinzer, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Adam Ogna, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)
Valentina Forni Ogna, MD principal investigator
Service de Néphrologie et Hypertension - Centre Hospitalier Universitaire Vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal transplantation in people with Obstructive Sleep Apnea and Overhydration, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the obstructive sleep apnea severity (time frame: six months after renal transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.