Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.

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Detailed Description

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The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:

• Apnea-Hypopnea Index (AHI)

Conditions

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Sleep Disordered Breathing Sleep Apnea, Central

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BiPAP auto SV Advanced

Group Type ACTIVE_COMPARATOR

BiPAP auto Advanced

Intervention Type DEVICE

Auto Servo Ventilation Device

BiPAP auto SV 4

Auto Servo Ventilation Device

Group Type EXPERIMENTAL

BiPAP auto SV4

Intervention Type DEVICE

Auto Servo Ventilation Device

Interventions

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BiPAP auto Advanced

Auto Servo Ventilation Device

Intervention Type DEVICE

BiPAP auto SV4

Auto Servo Ventilation Device

Intervention Type DEVICE

Other Intervention Names

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BiPAP Auto SV BiPAP Auto SV

Eligibility Criteria

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Inclusion Criteria

* Age 21-80
* Ability to provide consent
* Documentation of medical stability by investigator
* Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.

OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.

* Agreement to undergo a full-night, in-lab research CPAP Titration
* Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices

Exclusion Criteria

* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
* Systolic blood pressure \< 80 mm Hg at Baseline Visit.
* Participants in whom PAP therapy is otherwise medically contraindicated.
* Participants who are unwilling to wear CPAP
* Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Participants with untreated, non-obstructive Sleep Apnea (OSA)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15).

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes