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

Philips

Status

Completed

Conditions

Sleep Disordered Breathing

Sleep Apnea, Central

Treatments

Device: BiPAP auto Advanced

Device: BiPAP auto SV4

Study type

Interventional

Funder types

Industry

Identifiers

NCT01626989

ST-1007-ASV4-MS

Details and patient eligibility

About

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.

Full description

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)

Enrollment

44 patients

Sex

All

Ages

21 to 80 years old

Volunteers

Accepts Healthy Volunteers

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).