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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01626989
First received: May 19, 2011
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Sleep Disordered Breathing
Sleep Apnea, Central
Device: BiPAP auto Advanced
Device: BiPAP auto SV4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Apnea-Hypopnea Index (AHI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    AHI will be determined will be determined across each PSG night


Secondary Outcome Measures:
  • REM, NREM and Total Sleep Time (TST) Indices [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    REM, NREM and Total Sleep Time (TST) Indices

  • Central Apnea Index(CAI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Central Apnea Index(CAI)

  • Obstructive Apnea Index (OAI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Obstructive Apnea Index (OAI)

  • Mixed Apnea Index (MAI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Mixed Apnea Index (MAI)

  • Sleep Onset Latency (SOL) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Sleep Onset Latency (SOL)

  • REM Onset Latency (ROL) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    REM Onset Latency (ROL)

  • Wake After Sleep Onset (WASO) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Wake After Sleep Onset (WASO)

  • Total Sleep Time (TST) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Total Sleep Time (TST)

  • Sleep Efficiency (SE %) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Sleep Efficiency (SE %)

  • Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)

  • Arousal Index [total, AH-related, PLM-related, 'spontaneous'] [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Arousal Index [total, AH-related, PLM-related, 'spontaneous']

  • Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)

  • Hypopnea Index (HI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Hypopnea Index (HI)


Enrollment: 20
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BiPAP auto SV Advanced
BiPAP auto SV Advanced
Device: BiPAP auto Advanced
Auto Servo Ventilation Device
Other Name: BiPAP Auto SV
Experimental: BiPAP auto SV 4
Auto Servo Ventilation Device
Device: BiPAP auto SV4
Auto Servo Ventilation Device
Other Name: BiPAP Auto SV

Detailed Description:

The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:

• Apnea-Hypopnea Index (AHI)

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21-80
  • Ability to provide consent
  • Documentation of medical stability by investigator
  • Subjects who currently have been on PAP therapy for ≥ 4 weeks and who previously had a 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 PSG on BiPAP autoSV devices

Exclusion Criteria:

  • 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-OSA/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626989

Locations
United States, Arkansas
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States, 72205
United States, Michigan
Sleep Health
Portage, Michigan, United States, 49024
United States, Ohio
Sleepcare Diagnostics
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Shahrokh Javaheri, MD Sleepcare Diagnostics
Principal Investigator: Paul Wylie, MD Arkansas Center for Sleep Medicine
Principal Investigator: Mark Goetting, MD Sleep Health
  More Information

No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01626989     History of Changes
Other Study ID Numbers: ST-1007-ASV4-MS
Study First Received: May 19, 2011
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea, Central
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014