Bipap autoSV Advanced in Central Apnea Patients



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 75
Updated:11/30/-0001
Start Date:September 2010
End Date:May 2013

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BiPAP autoSV Advanced in Central Apnea Patients, ST-1001-ASVWO-MS


Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab PSG and 3
months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or
Complex Sleep Apnea.


Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one
full night attended CPAP titration, and one full night attended BiPAP autoSV Advanced
titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90
days.

Inclusion Criteria:

1. Males and females, ages 21-75.

2. Able and willing to provide written informed consent.

3. 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.

1. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3
cycles of crescendo-decrescendo breathing amplitude AND either a CAI ≥ 5/hour OR
the crescendo-decrescendo cycles last at least 10 consecutive minutes from an
attended Diagnostic PSG.

2. For participants diagnosed with Central Sleep Apnea with current daily Opioid
use or any other predominant central sleep apnea, an AHI ≥ 15 and CAI > 5 from
an attended Diagnostic PSG.

3. For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI > 5
from a CPAP titration.

4. Systolic blood pressure > 80 mm Hg at Visit 1.

5. Agreement to undergo a full-night, attended Diagnostic PSG.

6. Agreement to undergo a full-night, attended CPAP titration PSG.

7. Agreement to undergo a full-night, attended BiPAP autoSV Advanced titration PSG

Exclusion Criteria:

1. Active participation in another interventional research study.

2. Diagnosis of acute decompensated heart failure.

3. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.

4. 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.

5. Qualifying for or awaiting heart transplantation.

6. Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).

7. At home treatment with ASV or Bilevel PAP therapies.

8. Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or
cognitive (e.g. dementia) issues.

9. Participants in whom PAP therapy is medically contraindicated.

10. Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).

11. Narcolepsy.

12. Untreated Restless Legs Syndrome.

13. Periodic Limb Movement arousal index > 20/hr.
We found this trial at
3
sites
Wallingford, Connecticut 06492
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Wallingford, CT
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Louisville, Kentucky 40217
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Louisville, KY
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Mason, Ohio 45040
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Mason, OH
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