Health TrialsbyHealthPanel

Pacemaker-based Long-term Monitoring of Sleep Apnea

ConditionBradycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

This is a prospective, non-interventional cohort study. It tests the hypothesis that

* Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and/or device-detected sleep apnea. * Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and/or device-detected sleep apnea. * Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes. * Burden / variation of device-detected sleep apnea and/or device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device

signed informed consent

Disqualifiers

any contraindication to perform a cardiac CT examination

eGFR < 30 ml/min/1.73 m2

allergy against CT contrast medium

hyperthyreoism

Trial population

Patients with pacemakers are usually above the age of 65 years, and suffer from common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency, sleep disordered breathing, obesity and/or physical inactivity / de-conditioning.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 3 trial groups
Group A: patients with severe sleep apnea
Group B: patients with autonomic imbalance
Group C: patients with a sedentary lifestyle

Trial outcomes

Primary outcomes

1

3P-MACE

death, myocardial infarction and/or stroke

Time frame
time to first event, follow up for 120 months
2

device-detected atrial fibrillation

first episode lasting more than 6 minutes or 24 hours

Time frame
time to first event, follow up for 120 months
3

device-detected atrial fibrillation

total burden

Time frame
after 1, 3, 5 years
4

device-detected sleep apnea

severity (RDI \< versus \> 20/h)

Time frame
after 1, 3, 5 years

Secondary outcomes

1

incidence of common opthalmological disease

in correlation to device-detected sleep apnea and device-detected atrial fibrillation

Time frame
assessed within the first year after study enrollment
2

Deterioration of lung function

conventional lung function testing

Time frame
after 5 years
3

Progression of subclinical peripheral artery disease

sonography

Time frame
after 5 years
4

Progression of subclinical peripheral artery disease

ABI

Time frame
after 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University Innsbruck

Lead sponsor

Source ClinicalTrials.gov
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