Obstructive Sleep Apnea Clinical Trial
Official title:
Impact of Continues Positive Airway Pressure Treatment in Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea (RIDA)
The aim of this randomized controlled study is to investigate the effect of continues
positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and
concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function
measured by magnetic resonance (improvement of at least 4%) after six months treatment with
CPAP.
The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality
of life.
Sleep apnea, either obstructive (OSA) and central (CSA), occurs in more than half of all
patients with heart failure (HF), and is associated with poor prognosis in these individuals.
Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy and is defined as the
presence of the left ventricle dilatation and left ventricular systolic dysfunction without
concurrent valvular or coronary artery disease. Its etiology is unclear, but a genetic
component is present in at least 25% of cases. In younger individuals, the etiology is more
heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with
pregnancy, s.c. peripartum cardiomyopathy. Other underlying causes include alcohol, drugs,
pharmaceuticals, endocrine disorders, systemic diseases and general muscle. These factors
account for approximately half the cases of DCM in younger and other half designated as
idiopathic (IDCM).
The relationship between cardiomyopathies and OSA is insufficiently studied so far. In a
smaller population of 20 individuals with DCM, sleep apnea (OSA or CSA) had 16, ie 80% of
patients. The first-line treatment of OSA is continues positive pressure breathing mask
(CPAP) during sleep in patients with daytime sleepiness. Effect of CPAP therapy in patients
with DCM and OSA is completely unknown, because many of them do not report daytime
sleepiness. The fact that patients with heart failure and reduced pumping function usually
have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due
to heart failure and what is related to sleep apnea. Interpretation of the Epworth Sleepiness
Scale (ESS) is thus difficult and possibly unsure why all patients with DCM and OSA will be
randomized to treatment with CPAP.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |