Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device (SV3-ST)

This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.

Study Overview

• Status: Terminated
• Conditions: Sleep Disordered Breathing
• Intervention / Treatment: Device: BiPAP S/T; Device: BiPAP Auto SV3

Detailed Description

Primary Hypothesis and end-point:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:

• Apnea-Hypopnea Index (AHI)

Secondary Hypothesis and end-points:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:

• Sleep Variables
• REM, NREM and Total Sleep Time (TST) Indices
• Apnea Hypopnea Index (AHI)
• Center Apnea Index(CAI)
• Obstructive Apnea Index (OAI)
• Mixed Apnea Index (MAI)
• Hypopnea Index (HI)
• Sleep Onset Latency (SOL)
• REM Onset Latency (ROL)
• Wake After Sleep Onset (WASO)
• Total Sleep Time (TST)
• Sleep Efficiency (SE %)
• Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)
• Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)
• Arousal Index [total, AH-related, PLM-related, 'spontaneous']
• Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)
• AHI (REM, NREM and TST) using modified hypopnea rule.
• AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • Med One Medical Sleep Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 21-80.
• Ability to provide consent.
• Documentation of medical stability by investigator.
• Currently using BiPAP S/T (At least 4 weeks on therapy).
• Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.

Exclusion Criteria:

• Participants, who are acutely ill, medically complicated or who are medically unstable.
• Participants in whom PAP therapy is otherwise medically contraindicated.
• Participants who are unwilling to wear PAP.
• Participants who are currently prescribed oxygen therapy.
• 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)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index > 15).
• Participants who are unwilling to participate in the study.

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: Respironics BiPAP S/T; Control Arm using Respironics BiPAP S/T	Device: BiPAP S/T; Mechanical Non-invasive Ventilation; Other Names: Respironics BiPAP S/T
Active Comparator: Respironics BiPAP Auto SV3; Treatment arm using Respironics BiPAP Auto SV3	Device: BiPAP Auto SV3; Auto Servo Ventilation Device; Other Names: Respironics BiPAP auto SV Advanced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index	The number of apneas and hypopneas per hour of sleep.	2 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index- REM	The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).	2 nights
Central Apnea Index	The central apnea index is the number of central apneas divided by the number of hours of sleep.	2 nights
Obstructive Apnea Index	The obstructive apnea index is the number of obstructive apneas per hour of sleep.	2 nights
Mixed Apnea Index	The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.	2 nights
Hypopnea Index	The hypopnea index is number hypopneas per hour.	2 nights
Sleep Onset Latency	Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.	2 nights
REM Onset Latency	REM Onset Latency is the time it takes to fall into REM sleep.	2 nights
Wake After Sleep Onset	Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.	2 nights
Total Sleep Time	Total Sleep time is total amount of time a participant is asleep from lights off to lights on.	2 nights
Sleep Efficiency	Sleep Efficiency is the percentage of time spent asleep while in bed.	2 nights
Periodic Limb Movement Index	The periodic limb movement is the number of periodic limb movements per hour of sleep.	2 nights
Arousal Index	The arousal index is the number of arousals or awakenings per hour of sleep.	2 nights
Stages N1,N2,N3 and REM (R) Sleep (% TST)	The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.	2 nights
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)	The average amount of time spent N1, N2, N3 and REM in minutes per night.	2 nights
Nocturnal Oxygenation Index	Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.	2 nights
Apnea Hypopnea Index Using Modified Hypopnea Rule.	The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.	2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.	The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.	2 nights

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Brydon Grant, MD, Medical Director of Med One Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: MR-0830-ASV3-ST-SS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes