Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
This study has been completed.
Information provided by (Responsible Party):
First received: September 9, 2010
Last updated: March 28, 2016
Last verified: March 2016
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.
Sleep Apnea, Central
Device: BiPAP autoSV Advanced
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
Primary Outcome Measures:
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.
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||21 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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).
- Untreated Restless Legs Syndrome.
- Periodic Limb Movement arousal index > 20/hr.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199042
|Gaylord Hospital - Gaylord Sleep Research
|Wallingford, Connecticut, United States, 06492 |
|Kentucky Research Group
|Louisville, Kentucky, United States, 40217 |
|Mason, Ohio, United States, 45040 |
||Shahrokh Javaheri, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 9, 2010
|Results First Received:
||August 5, 2015
||March 28, 2016
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 27, 2016
Sleep Apnea, Central
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases