Bipap autoSV Advanced in Central Apnea Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01199042
First received: September 9, 2010
Last updated: August 21, 2013
Last verified: August 2013

September 9, 2010
August 21, 2013
September 2010
May 2013   (final data collection date for primary outcome measure)
AHI [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]
To compare the AHI during full night, attended BiPAP autoSV Advanced titration PSG to the full night, attended Diagnostic PSG.
Same as current
Complete list of historical versions of study NCT01199042 on ClinicalTrials.gov Archive Site
  • AHI [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]
    To compare the AHI (both the overall AHI and AHI at optimal pressure) from the full night attended CPAP titration PSG to the full night attended BiPAP autoSV Advanced titration PSG.
  • Epworth Sleepiness Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Visit 1 and Visit 6.
  • Breathing event indexes [ Time Frame: During one night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]
    To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.
  • Therapy pressure values [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.
Same as current
Not Provided
Not Provided
 
Bipap autoSV Advanced in Central Apnea Patients
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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cheyne-Stokes Respiration
  • Sleep Apnea, Central
Device: BiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
BiPAP autoSV Advanced Device
Intervention: Device: BiPAP autoSV Advanced
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199042
ST-1001-ASVWO-MS
No
Philips Respironics
Philips Respironics
Not Provided
Not Provided
Philips Respironics
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP