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Completed

NCT Number: NCT01199042

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.

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Key information

Conditions

Cheyne-Stokes Respiration Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaylord Hospital - Gaylord Sleep Research, Wallingford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BiPAP autoSV Advanced

Device

The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.

Primary outcomes

  1. Apnea/Hypopnea Index (AHI)

    Time frame: During a single night of polysomnography lasting up to 8 hours.

    To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.

Secondary outcomes

  1. Epworth Sleepiness Scale

    Time frame: 3 months

    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.

  2. 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

    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.

  3. Average Therapy Pressure Values

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2010
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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