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

Not Applicable

Completed

Conditions: Sleep Disordered Breathing
Sleep Apnea, Central

Interventions: Device: BiPAP auto Advanced
Device: BiPAP auto SV4

Registration Number: NCT01626989

Lead Sponsor: Philips Respironics

Brief Summary: 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.

Detailed 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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BiPAP auto SV Advanced	BiPAP auto Advanced	BiPAP auto SV Advanced
BiPAP auto SV 4	BiPAP auto SV4	Auto Servo Ventilation Device

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	Baseline, and 2 nights (1 night for each intervention)	Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

Secondary Outcome Measures

Name	Time	Method
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices	Baseline, and 2 nights (1 night for each intervention)	REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Obstructive Apnea Index (OAI)	Baseline, and 2 nights (1 night for each intervention)	Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.
REM Onset Latency (ROL)	Baseline, and 2 nights (1 night for each intervention)	REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.
Wake After Sleep Onset (WASO)	Baseline, and 2 nights (1 night for each intervention)	Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.
Sleep Onset Latency (SOL)	Baseline, and 2 nights (1 night for each intervention)	Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.
Sleep Efficiency (SE %)	Baseline, and 2 nights (1 night for each intervention)	Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.
Hypopnea Index (HI)	Baseline, and 2 nights (1 night for each intervention)	Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.
Central Apnea Index(CAI)	Baseline, and 2 nights (1 night for each intervention)	Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep	Baseline, and 2 nights (1 night for each intervention)	Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from "lights out," or bedtime, to the onset of sleep.
Arousal Index	Baseline, and 2 nights (1 night for each intervention)	Arousal Index is the number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep.
Mixed Apnea Index (MAI)	Baseline, and 2 nights (1 night for each intervention)	Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.
Total Sleep Time (TST)	Baseline, and 2 nights (1 night for each intervention)	Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Nocturnal Oxygenation	Baseline, and 2 nights (1 night for each intervention)	Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.

Trial Locations

Locations (3): Sleepcare Diagnostics
🇺🇸
Mason, Ohio, United States
Sleep Health
🇺🇸
Portage, Michigan, United States
Arkansas Center for Sleep Medicine
🇺🇸
Little Rock, Arkansas, United States