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

NCT01626989 | Completed Results

• 1 other identifier: ST-1007-ASV4-MS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sleep Disordered Breathing; Sleep Apnea, Central

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.

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

Secondary Outcomes (13)

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

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

• Central Apnea Index(CAI)

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

• Obstructive Apnea Index (OAI)

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

• Mixed Apnea Index (MAI)

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

• Sleep Onset Latency (SOL)

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

Study Arms (2)

BiPAP auto SV Advanced

ACTIVE COMPARATOR

BiPAP auto SV Advanced

Device: BiPAP auto Advanced

BiPAP auto SV 4

EXPERIMENTAL

Auto Servo Ventilation Device

Device: BiPAP auto SV4

Interventions

BiPAP auto Advanced DEVICE

Auto Servo Ventilation Device

Also known as: BiPAP Auto SV

BiPAP auto SV Advanced

BiPAP auto SV4 DEVICE

Auto Servo Ventilation Device

Also known as: BiPAP Auto SV

BiPAP auto SV 4

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (3)

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72205, United States

Location

Sleep Health

Portage, Michigan, 49024, United States

Location

Sleepcare Diagnostics

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Jeremy Powers
• Organization: Philips

jeremy.powers@philips.com

412-542-3669

Study Officials

• Shahrokh Javaheri, MD

  Sleepcare Diagnostics

  PRINCIPAL INVESTIGATOR

• Paul Wylie, MD

  Arkansas Center for Sleep Medicine

  PRINCIPAL INVESTIGATOR

• Mark Goetting, MD

  Sleep Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: June 25, 2012
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 25, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-04

Locations

US (3)