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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cheyne-Stokes Respiration Sleep Apnea, Central

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BiPAP autoSV Advanced Device

Positive airway pressure device

Group Type OTHER

BiPAP autoSV Advanced

Intervention Type DEVICE

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

Interventions

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BiPAP autoSV Advanced

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No