Clinical trial NCT00720213: Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
Official title: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Sleep Apnea, Central
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) 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.

Detailed description: This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).

Study Design: A prospective, multicenter, randomized, controlled trial.

Setting: Five sleep laboratories in the United States.

Participants: Thirty-seven participants were included.

Eligibility criteria: Inclusion Criteria:

Pre-Study Inclusion Criteria:

* Age 21-80
* Ability to provide consent
* Documentation of medical stability by investigator

Enrollment Inclusion Criteria:

• Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5

or

• Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.

Exclusion Criteria:

* • Participants who are acutely ill, medically complicated or who are medically unstable.

  * Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
  * Participants in whom PAP therapy is otherwise medically contraindicated.
  * Participants who are unwilling to wear CPAP
  * Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
  * 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 (PLM Arousal Index \> 15).
  * Participants who are unwilling to participate in the study.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 2 nights
Secondary outcomes:
measure: Apnea Hypopnea Index- REM and NREM
timeFrame: 2 nights
measure: Central Apnea Index
timeFrame: 2 nights
measure: Obstructive Apnea Index
timeFrame: 2 nights
measure: Mixed Apnea Index
timeFrame: 2 nights
measure: Hypopnea Index
timeFrame: 2 nights
measure: Sleep Onset Latency
timeFrame: 2 nights
measure: Rapid Eye Movement (REM) Onset Latency
timeFrame: 2 nights
measure: Wake After Sleep Onset
timeFrame: 2 nights
measure: Total Sleep Time
timeFrame: 2 nights
measure: Sleep Efficiency
timeFrame: 2 nights
measure: Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
timeFrame: 2 nights
measure: Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
timeFrame: 2 nights
measure: Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
timeFrame: 2 nights
measure: Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
timeFrame: 2 nights
measure: Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
timeFrame: 2 nights
measure: Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
timeFrame: 2 nights
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Portage
country: United States
facility: Mark G. Goetting
state: Michigan
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Mason
country: United States
facility: Sleepcare Diagnostics
state: Ohio
Study officials:
affiliation: University of Arizona
name: Jamie Goodwin
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleepcare Diagnostics
name: Shahrokh Javaheri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State Univercity
name: Rami Khayat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Health
name: Mark Goetting, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arkansas Center for Sleep Medicine
name: Paul Wylie, MD
role: PRINCIPAL_INVESTIGATOR
References: