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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disordered Breathing; Sleep Apnea, Central
• Intervention / Treatment: Device: BiPAP auto Advanced; Device: BiPAP auto SV4

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)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Center for Sleep Medicine
  • Michigan
    • Portage, Michigan, United States, 49024
      • Sleep Health
  • Ohio
    • Mason, Ohio, United States, 45040
      • Sleepcare Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BiPAP auto SV Advanced	Device: BiPAP auto Advanced; Auto Servo Ventilation Device; Other Names: BiPAP Auto SV
Experimental: BiPAP auto SV 4; Auto Servo Ventilation Device	Device: BiPAP auto SV4; Auto Servo Ventilation Device; Other Names: BiPAP Auto SV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices	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	Baseline, and 2 nights (1 night for each intervention)
Central Apnea Index(CAI)	Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.	Baseline, and 2 nights (1 night for each intervention)
Obstructive Apnea Index (OAI)	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.	Baseline, and 2 nights (1 night for each intervention)
Mixed Apnea Index (MAI)	Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.	Baseline, and 2 nights (1 night for each intervention)
Sleep Onset Latency (SOL)	Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.	Baseline, and 2 nights (1 night for each intervention)
REM Onset Latency (ROL)	REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.	Baseline, and 2 nights (1 night for each intervention)
Wake After Sleep Onset (WASO)	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.	Baseline, and 2 nights (1 night for each intervention)
Total Sleep Time (TST)	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	Baseline, and 2 nights (1 night for each intervention)
Sleep Efficiency (SE %)	Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.	Baseline, and 2 nights (1 night for each intervention)
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep	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.	Baseline, and 2 nights (1 night for each intervention)
Arousal Index	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.	Baseline, and 2 nights (1 night for each intervention)
Nocturnal Oxygenation	Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.	Baseline, and 2 nights (1 night for each intervention)
Hypopnea Index (HI)	Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.	Baseline, and 2 nights (1 night for each intervention)

Collaborators and Investigators

• Sponsor: Philips Respironics

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Wake Disorders; Parasomnias; Sleep Apnea, Central
• Other Study ID Numbers: ST-1007-ASV4-MS