Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients (NCT01199042) | Clinical Trial Compass
CompletedNot Applicable
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
United States29 participantsStarted 2010-09
Plain-language summary
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and females, ages 21-75.
✓. Able and willing to provide written informed consent.
✓. Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
✓. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
✓. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI \> 5 from an attended Diagnostic PSG.
✓. For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI \> 5 from a CPAP titration.
✓. Systolic blood pressure \> 80 mm Hg at Visit 1.
✓. Agreement to undergo a full-night, attended Diagnostic PSG.
Exclusion criteria
✕. Active participation in another interventional research study.
✕. Diagnosis of acute decompensated heart failure.
✕. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
What they're measuring
1
Apnea/Hypopnea Index (AHI)
Timeframe: During a single night of polysomnography lasting up to 8 hours.
. Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
✕. Qualifying for or awaiting heart transplantation.
✕. Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
✕. At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
✕. Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.