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

NCT ID: NCT01241604

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-07-31

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

Conditions

Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Respironics BiPAP S/T

Control Arm using Respironics BiPAP S/T

Group Type: ACTIVE_COMPARATOR

BiPAP S/T

Intervention Type: DEVICE

Mechanical Non-invasive Ventilation

Respironics BiPAP Auto SV3

Treatment arm using Respironics BiPAP Auto SV3

Group Type: ACTIVE_COMPARATOR

BiPAP Auto SV3

Intervention Type: DEVICE

Auto Servo Ventilation Device

Interventions

BiPAP S/T

Mechanical Non-invasive Ventilation

Intervention Type: DEVICE

BiPAP Auto SV3

Auto Servo Ventilation Device

Intervention Type: DEVICE

Other Intervention Names

Respironics BiPAP S/T; Respironics BiPAP auto SV Advanced

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brydon Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director of Med One Medical

Locations

Med One Medical Sleep Laboratory

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

MR-0830-ASV3-ST-SS

Identifier Type: -

Identifier Source: org_study_id