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A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV. (autoSVREGDE)

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Philips

Status

Completed

Conditions

Mixed Sleep Apnea
Cheyne-Stokes Respiration
Central Sleep Apnea
Complex Sleep Apnea

Treatments

Device: DreamStation BiPAP autoSV

Study type

Observational

Funder types

Industry

Identifiers

NCT03421704
SRC-SLE-ASVREGDE-2017-10032

Details and patient eligibility

About

This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy. This registry is intended to characterize the patient populations that may benefit from DreamStation BiPAP autoSV therapy (PR DS-autoSV, Philips Respironics, Monroeville, PA) in real life settings. In addition, this registry will assess adherence to the PR DS-autoSV therapy, the therapeutic benefits, collect morbidity and mortality data of servo ventilation in patients with central sleep apnea (CSA) and complex sleep-disordered breathing (SDB).

Enrollment

129 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Indication and prescription of PR DS-autoSV
  • Polysomnographic (PSG) or Polygraphic (PG) documentation of sleep-disordered breathing requiring servo ventilation

Exclusion criteria

  • Patients with HFrEF - heart failure and low ejection fraction (EF ≤ 45%) and predominant CSA (> 50 % of events)
  • Patients not able to receive positive airway pressure support through a mask due to surgical procedure or anatomical condition
  • Chronic conditions with life expectancy < 1 year
  • Significant chronic obstructive pulmonary disease (COPD) with an FEV1/VC < 70% (GOLD III)
  • Respiratory insufficiency requiring long-term oxygen therapy
  • Daytime hypercapnia at rest (pCO2 > 45 mmHg)
  • Cardiac surgery, PCI, myocardial infarction, unstable angina, within 12 weeks prior to enrolment
  • Cardiac resynchronization or pacemaker implantation within the last 6 months
  • Untreated or therapy refractory Restless legs-Syndrome (RLS)

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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