Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Sleep Disordered Breathing Clinical Trial

— SV3-ST  

Official title:

Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01241604
• Other study ID #: MR-0830-ASV3-ST-SS
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: March 2019
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

Device:
• BiPAP S/T
Mechanical Non-invasive Ventilation
• BiPAP Auto SV3
Auto Servo Ventilation Device

Locations

Country	Name	City	State
United States	Med One Medical Sleep Laboratory	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index	The number of apneas and hypopneas per hour of sleep.	2 nights
Secondary	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
Secondary	Central Apnea Index	The central apnea index is the number of central apneas divided by the number of hours of sleep.	2 nights
Secondary	Obstructive Apnea Index	The obstructive apnea index is the number of obstructive apneas per hour of sleep.	2 nights
Secondary	Mixed Apnea Index	The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.	2 nights
Secondary	Hypopnea Index	The hypopnea index is number hypopneas per hour.	2 nights
Secondary	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
Secondary	REM Onset Latency	REM Onset Latency is the time it takes to fall into REM sleep.	2 nights
Secondary	Wake After Sleep Onset	Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.	2 nights
Secondary	Total Sleep Time	Total Sleep time is total amount of time a participant is asleep from lights off to lights on.	2 nights
Secondary	Sleep Efficiency	Sleep Efficiency is the percentage of time spent asleep while in bed.	2 nights
Secondary	Periodic Limb Movement Index	The periodic limb movement is the number of periodic limb movements per hour of sleep.	2 nights
Secondary	Arousal Index	The arousal index is the number of arousals or awakenings per hour of sleep.	2 nights
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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