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
  Purpose
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.

Condition Intervention
Cheyne-Stokes Respiration
Sleep Apnea, Central
Device: BiPAP autoSV Advanced

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 29
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BiPAP autoSV Advanced Device
Positive airway pressure device
Device: BiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.

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 autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199042

Locations
United States, Connecticut
Gaylord Hospital - Gaylord Sleep Research
Wallingford, Connecticut, United States, 06492
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40217
United States, Ohio
Sleepcare Diagnostics
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Shahrokh Javaheri, MD Sleepcare Diagnostics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01199042     History of Changes
Other Study ID Numbers: ST-1001-ASVWO-MS 
Study First Received: September 9, 2010
Results First Received: August 5, 2015
Last Updated: March 28, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Cheyne-Stokes Respiration
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 30, 2016