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Completed

NCT Number: NCT01626989

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.

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Center for Sleep Medicine, Little Rock, Arkansas, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BiPAP auto Advanced

Device

Auto Servo Ventilation Device

Other names: BiPAP Auto SV

BiPAP auto SV4

Device

Auto Servo Ventilation Device

Other names: BiPAP Auto SV

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: 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 outcomes

  1. Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices

    Time frame: 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

  2. Central Apnea Index(CAI)

    Time frame: 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.

  3. Obstructive Apnea Index (OAI)

    Time frame: 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.

  4. Mixed Apnea Index (MAI)

    Time frame: 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.

  5. Sleep Onset Latency (SOL)

    Time frame: 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.

  6. REM Onset Latency (ROL)

    Time frame: 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.

  7. Wake After Sleep Onset (WASO)

    Time frame: 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.

  8. Total Sleep Time (TST)

    Time frame: 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

  9. Sleep Efficiency (SE %)

    Time frame: Baseline, and 2 nights (1 night for each intervention)

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

  10. Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep

    Time frame: 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.

  11. Arousal Index

    Time frame: 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.

  12. Nocturnal Oxygenation

    Time frame: Baseline, and 2 nights (1 night for each intervention)

    Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.

  13. Hypopnea Index (HI)

    Time frame: Baseline, and 2 nights (1 night for each intervention)

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

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 25, 2012
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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