Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
1 other identifier
interventional
29
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
April 28, 2016
CompletedApril 28, 2016
March 1, 2016
2.7 years
September 9, 2010
August 5, 2015
March 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea/Hypopnea Index (AHI)
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
During a single night of polysomnography lasting up to 8 hours.
Secondary Outcomes (3)
Epworth Sleepiness Scale
3 months
Breathing Event Indexes
from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
Average Therapy Pressure Values
3 months
Study Arms (1)
BiPAP autoSV Advanced Device
OTHERPositive airway pressure device
Interventions
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Gaylord Hospital - Gaylord Sleep Research
Wallingford, Connecticut, 06492, United States
Kentucky Research Group
Louisville, Kentucky, 40217, United States
Sleepcare Diagnostics
Mason, Ohio, 45040, United States
Related Publications (1)
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.
PMID: 25950507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shahrokh Javaheri
- Organization
- Bethesda North Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Shahrokh Javaheri, MD
Sleepcare Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 10, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 28, 2016
Results First Posted
April 28, 2016
Record last verified: 2016-03