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Bipap Automatic Servo Ventilation (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: March 28, 2016
Last verified: March 2016

September 9, 2010
March 28, 2016
September 2010
May 2013   (final data collection date for primary outcome measure)
Apnea/Hypopnea Index (AHI) [ Time Frame: During a single night of polysomnography lasting up to 8 hours. ] [ Designated as safety issue: No ]
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
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.
Complete list of historical versions of study NCT01199042 on ClinicalTrials.gov Archive Site
  • 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 Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.

    Interpretation:

    Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.

    Score 16-24: Excessive sleepiness and patient should consider seeking medical attention

    A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness.

  • Breathing Event Indexes [ Time Frame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment ] [ 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.

    Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment.

  • Average 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.

    This analysis compares the average pressure support of the first week compared to the average pressure support to the final week.

  • 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.
Not Provided
Not Provided
 
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
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.
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 autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
Interventional
Not Provided
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
Positive airway pressure device
Intervention: Device: BiPAP autoSV Advanced
Javaheri S, Winslow D, McCullough P, Wylie P, Kryger MH. The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea. Chest. 2015 Dec;148(6):1454-61. doi: 10.1378/chest.14-2966.

*   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 Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
    2. 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.
    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 automatic Servo Ventilation (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 adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199042
ST-1001-ASVWO-MS
No
Not Provided
Not Provided
Philips Respironics
Philips Respironics
Not Provided
Principal Investigator: Shahrokh Javaheri, MD Sleepcare Diagnostics
Philips Respironics
March 2016

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