Status:
COMPLETED
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Lead Sponsor:
Philips Respironics
Conditions:
Cheyne-Stokes Respiration
Sleep Apnea, Central
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP ...
Eligibility Criteria
Inclusion
- 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.
- Agreement to undergo a full-night, attended CPAP titration PSG.
- Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
Exclusion
- 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.
- 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.
- Participants in whom PAP therapy is medically contraindicated.
- Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
- Narcolepsy.
- Untreated Restless Legs Syndrome.
- Periodic Limb Movement arousal index \> 20/hr.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01199042
Start Date
September 1 2010
End Date
May 1 2013
Last Update
April 28 2016
Active Locations (3)
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1
Gaylord Hospital - Gaylord Sleep Research
Wallingford, Connecticut, United States, 06492
2
Kentucky Research Group
Louisville, Kentucky, United States, 40217
3
Sleepcare Diagnostics
Mason, Ohio, United States, 45040