Sleep ApneaSAPAADNCT02751021
Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction
A study testing pacemaker diagnostic algorithm and Attended cardiorespiratory sleep study in people with Sleep Apnea and Arrhythmias, Cardiac, run by University Hospital, Caen at 1 site in France.
Trial summary
Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Arrhythmias, Cardiac, Cardiac Diastolic Function
- What is being tested?
- pacemaker diagnostic algorithm and Attended cardiorespiratory sleep study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2016to Jun 2019
- 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
- indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia)
- Diastolic dysfunction diagnosed at the transthoracic echocardiography
Who cannot join
- younger than 18 years old
- lack of informed consent form
- impossibility to fit in the scheduled study plan
- indication for cardiac resynchronization or left ventricular ejection fraction lower than 45%
- indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study
Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea.
The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.
- Being tested
- pacemaker diagnostic algorithm, Attended cardiorespiratory sleep study
- Medical subject headings
- Sleep Apnea Syndromes, Arrhythmias, Cardiac, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemaker diagnostic algorithmOther
evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea
Attended cardiorespiratory sleep studyOther
sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea diagnosis | Other | The intervention is the use of the pacemaker diagnostic algorithm named Sleep Apnea Monitoring to detect sleep apnea and the attended cardiorespiratory sleep study to confirm the diagnostic. Receives: Other: pacemaker diagnostic algorithm; Other: Attended cardiorespiratory sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index
number of apneas and hypopneas per hour (5 hours recorded by night) evaluated by the pacemaker algorithm during the night of the attended cardiorespiratory sleep study compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study
Measured: 2 months after pacemaker implantation
Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index
Average value of respiratory disturbance index recorded each night during the last month compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study
Measured: 2 months after pacemaker implantation
Secondary outcomes (1)
Measurement of plasmatic aldosterone and correlation with apnea hypopnea index
Measured: 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start22 Jun 2016
- Primary completionJun 2019
- Study completionJun 2019
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 Sleep ApneaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Responsible party
- Sponsor
- Investigators
- Laure CHAMP-RIGOT, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751021
- Sponsor's protocol ID
- 2016-A00034-47
- Acronym
- SAPAAD
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2016
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Champ-Rigot L, Ferchaud V, Prevost JN, Moirot P, Pellissier A, Legallois D, Alexandre J, Scanu P, Morello R, Saloux E, Milliez PU. Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). Clin Med Insights Cardiol. 2018 Jan 8;12:1179546817751628. doi: 10.1177/1179546817751628. eCollection 2018.
PubMed 29343998
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study
- ClinicalTrials.gov ID
- NCT02751021
- Acronym / sponsor ID
- SAPAAD / 2016-A00034-47
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 26 Apr 2016 (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.
Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea.
The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea diagnosis | Other | Other: pacemaker diagnostic algorithm, Other: Attended cardiorespiratory sleep studyThe intervention is the use of the pacemaker diagnostic algorithm named Sleep Apnea Monitoring to detect sleep apnea and the attended cardiorespiratory sleep study to confirm the diagnostic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia)
- Diastolic dysfunction diagnosed at the transthoracic echocardiography
Key exclusion criteria (5 listed)
- younger than 18 years old
- lack of informed consent form
- impossibility to fit in the scheduled study plan
- indication for cardiac resynchronization or left ventricular ejection fraction lower than 45%
- indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure
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 |
|---|---|---|
| pacemaker diagnostic algorithmevaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea | Other | Sleep apnea diagnosis |
| Attended cardiorespiratory sleep studysleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis | Other | Sleep apnea diagnosis |
Primary outcome
Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index
Time frame: 2 months after pacemaker implantation
number of apneas and hypopneas per hour (5 hours recorded by night) evaluated by the pacemaker algorithm during the night of the attended cardiorespiratory sleep study compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study
Comparison between the mean respiratory disturbance index of the last month and Apnea hypopnea index
Time frame: 2 months after pacemaker implantation
Average value of respiratory disturbance index recorded each night during the last month compared to the apnea hypopnea index evaluated by the portable monitor during the attended cardiorespiratory sleep study
1 secondary outcome
Measurement of plasmatic aldosterone and correlation with apnea hypopnea index
Time frame: 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients
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 2 Apr 2026.
- Background: PubMed 29343998Champ-Rigot L, Ferchaud V, Prevost JN, Moirot P, Pellissier A, Legallois D, Alexandre J, Scanu P, Morello R, Saloux E, Milliez PU. Rationale and Design for a Monocentric Prospective Study: Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction (SAPAAD Study). Clin Med Insights Cardiol. 2018 Jan 8;12:1179546817751628. doi: 10.1177/1179546817751628. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Laure CHAMP-RIGOT, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pacemaker diagnostic algorithm and Attended cardiorespiratory sleep study in people with Sleep Apnea and Arrhythmias, Cardiac, run by University Hospital, Caen at 1 site in France.
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 2 inclusion and 5 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 2 Apr 2026. 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 France. 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?
Comparison between respiratory disturbance index recorded the sleep study night and Apnea hypopnea index (time frame: 2 months after pacemaker implantation). The study lists 2 primary outcomes in all. 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 NCT02751021, 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 2 Apr 2026.