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

Primary Purpose

Sleep Disordered Breathing, Sleep Apnea, Central

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BiPAP auto Advanced

BiPAP auto SV4

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

Arkansas Center for Sleep Medicine
Sleep Health
Sleepcare Diagnostics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BiPAP auto SV Advanced

BiPAP auto SV 4

Arm Description

BiPAP auto SV Advanced

Auto Servo Ventilation Device

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index (AHI)

Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

Secondary Outcome Measures

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

Central Apnea Index(CAI)

Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.

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.

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.

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.

REM Onset Latency (ROL)

REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.

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.

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

Sleep Efficiency (SE %)

Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.

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.

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.

Nocturnal Oxygenation

Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.

Hypopnea Index (HI)

Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.

Full Information

NCT ID

NCT01626989

First Posted

May 19, 2011

Last Updated

April 23, 2019

Sponsor

Philips Respironics

1. Study Identification

Unique Protocol Identification Number

NCT01626989

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Respironics

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disordered Breathing, Sleep Apnea, Central

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BiPAP auto SV Advanced

Arm Type

Active Comparator

Arm Description

BiPAP auto SV Advanced

Arm Title

BiPAP auto SV 4

Arm Type

Experimental

Arm Description

Auto Servo Ventilation Device

Intervention Type

Device

Intervention Name(s)

BiPAP auto Advanced

Other Intervention Name(s)

BiPAP Auto SV

Intervention Description

Auto Servo Ventilation Device

Intervention Type

Device

Intervention Name(s)

BiPAP auto SV4

Other Intervention Name(s)

BiPAP Auto SV

Intervention Description

Auto Servo Ventilation Device

Primary Outcome Measure Information:

Title

Apnea-Hypopnea Index (AHI)

Description

Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

Time Frame