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Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

Primary Purpose

Cheyne-Stokes Respiration, Sleep Apnea, Central

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BiPAP autoSV Advanced
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cheyne-Stokes Respiration

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gaylord Hospital - Gaylord Sleep Research
  • Kentucky Research Group
  • Sleepcare Diagnostics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BiPAP autoSV Advanced Device

Arm Description

Positive airway pressure device

Outcomes

Primary Outcome Measures

Apnea/Hypopnea Index (AHI)
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.

Secondary Outcome Measures

Epworth Sleepiness Scale
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
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
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.

Full Information

First Posted
September 9, 2010
Last Updated
March 28, 2016
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT01199042
Brief Title
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Official Title
BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cheyne-Stokes Respiration, Sleep Apnea, Central

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiPAP autoSV Advanced Device
Arm Type
Other
Arm Description
Positive airway pressure device
Intervention Type
Device
Intervention Name(s)
BiPAP autoSV Advanced
Intervention Description
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
Primary Outcome Measure Information:
Title
Apnea/Hypopnea Index (AHI)
Description
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
Time Frame
During a single night of polysomnography lasting up to 8 hours.
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
3 months
Title
Breathing Event Indexes
Description
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.
Time Frame
from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
Title
Average Therapy Pressure Values
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Agreement to undergo a full-night, attended CPAP titration PSG. Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG Exclusion Criteria: Active participation in another interventional research study. Diagnosis of acute decompensated heart failure. 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. Participants in whom PAP therapy is medically contraindicated. Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg). Narcolepsy. Untreated Restless Legs Syndrome. Periodic Limb Movement arousal index > 20/hr.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrokh Javaheri, MD
Organizational Affiliation
Sleepcare Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaylord Hospital - Gaylord Sleep Research
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Sleepcare Diagnostics
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25950507
Citation
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):1454-1461. doi: 10.1378/chest.14-2966.
Results Reference
derived

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Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

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