Obstructive Sleep ApneaSASinHDNCT01860209
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients
A study testing Hemodialysis 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 decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. 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?
- Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Oct 2013
- 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 syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
- age ≥ 18 years
- patient with end stage renal disease on chronic intermittent hemodialysis
Who cannot join
- unstable congestive heart failure
- pace-maker
- 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: Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome 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 decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. 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 hypervolemia, including chronic renal failure.
The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.
The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.
- Being tested
- Hemodialysis
- Keywords
- obstructive sleep apnea, overhydration, end stage renal disease, intermittent ambulatory hemodialysis, polysomnography, bioimpedance, leg fluid shift, neck circumference
- Medical subject headings
- Sleep Apnea, Obstructive, Water Intoxication, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night Receives: Procedure: Hemodialysis |
| Group B | Experimental | the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night Receives: Procedure: Hemodialysis |
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, after an ambulatory hemodialysis session
Measured: two nights (before and after an ambulatory hemodialysis session)
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 after an ambulatory hemodialysis session
Measured: two nights (before and after an ambulatory hemodialysis session)
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
Measured: one night
severity of the periodic limb movement disorder (PLMD)
severity of the periodic limb movement disorder (PLMD)
Measured: two nights (before and after one hemodialysis session)
severity of central sleep apnea syndrome
severity of central sleep apnea syndrome
Measured: two nights (before and after one hemodialysis session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- Raphael Heinzer, MD, Principal investigator, Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860209
- Sponsor's protocol ID
- CIRS-SASinHD
- Acronym
- SASinHD
- Status last verified
- Dec 2013
- First submitted
- 18 May 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT01860209
- Acronym / sponsor ID
- SASinHD / CIRS-SASinHD
- Keywords
- obstructive sleep apnea, overhydration, end stage renal disease, intermittent ambulatory hemodialysis, polysomnography, bioimpedance, leg fluid shift, neck circumference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 May 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 decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. 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 hypervolemia, including chronic renal failure.
The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.
The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Hemodialysisthe first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night |
| Group B | Experimental | Procedure: Hemodialysisthe first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night |
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 syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
- age ≥ 18 years
- patient with end stage renal disease on chronic intermittent hemodialysis
Key exclusion criteria (4 listed)
- unstable congestive heart failure
- pace-maker
- 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 |
|---|---|---|
| HemodialysisIntermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study) | Procedure or surgery | Group A, Group B |
Primary outcome
Reduction of the obstructive sleep apnea severity
Time frame: two nights (before and after an ambulatory hemodialysis session)
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session
4 secondary outcomes
Reduction in nocturnal leg fluid volume shift between the legs and the neck
Time frame: two nights (before and after an ambulatory hemodialysis session)
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
Time frame: one night
severity of the periodic limb movement disorder (PLMD)
Time frame: two nights (before and after one hemodialysis session)
severity of central sleep apnea syndrome
Time frame: two nights (before and after one hemodialysis session)
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 20 Dec 2013.
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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.
Raphael Heinzer, MD principal investigator
Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis 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 4 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 20 Dec 2013. 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: two nights (before and after an ambulatory hemodialysis session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2013.