Clinical trial NCT01241604: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Official title: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Disordered Breathing
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 11
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 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 2 nights
Secondary outcomes:
measure: Apnea Hypopnea Index- REM
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: 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: Periodic Limb Movement Index
timeFrame: 2 nights
measure: Arousal Index
timeFrame: 2 nights
measure: Stages N1,N2,N3 and REM (R) Sleep (% TST)
timeFrame: 2 nights
measure: Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
timeFrame: 2 nights
measure: Nocturnal Oxygenation Index
timeFrame: 2 nights
measure: Apnea Hypopnea Index 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: Salt Lake City
country: United States
facility: Med One Medical Sleep Laboratory
state: Utah
Study officials:
affiliation: Medical Director of Med One Medical
name: Brydon Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: