Sleep Apnea Clinical Trial
— SAPAADOfficial title:
Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction: SAPAAD Study
NCT number | NCT02751021 |
Other study ID # | 2016-A00034-47 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2016 |
Est. completion date | June 2019 |
Verified date | August 2019 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital | Caen | Normandy |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | LivaNova |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 months after pacemaker implantation | |
Primary | 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 | 2 months after pacemaker implantation | |
Secondary | Measurement of plasmatic aldosterone and correlation with apnea hypopnea index | 2 months after pacemaker implantation and one month after the beginning of continuous positive airway pressure (CPAP) therapy in apneic patients |
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