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 range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apnea/Hypopnea Index (AHI)
Timeframe: During a single night of polysomnography lasting up to 8 hours.
. 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.