NCT00720213

Brief Summary

This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
9.6 years until next milestone

Results Posted

Study results publicly available

January 29, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

July 18, 2008

Results QC Date

August 11, 2010

Last Update Submit

January 4, 2019

Conditions

Sleep Disordered BreathingSleep Apnea, Central

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index

    The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.

    2 nights

Secondary Outcomes (16)

  • Apnea Hypopnea Index- REM and NREM

    2 nights

  • Central Apnea Index

    2 nights

  • Obstructive Apnea Index

    2 nights

  • Mixed Apnea Index

    2 nights

  • Hypopnea Index

    2 nights

  • +11 more secondary outcomes

Study Arms (2)

Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3

ACTIVE COMPARATOR

Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.

Device: Respironics BiPAP autoSV2Device: Respironics BiPAP autoSV3

Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2

EXPERIMENTAL

Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.

Device: Respironics BiPAP autoSV2Device: Respironics BiPAP autoSV3

Interventions

Respironics BiPAP autoSV2DEVICE

Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2
Respironics BiPAP autoSV3DEVICE

Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.

Also known as: Respironics BiPAP autoSV3 advanced
Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-80
  • Ability to provide consent
  • Documentation of medical stability by investigator
  • Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
  • Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.

You may not qualify if:

  • Participants who are acutely ill, medically complicated or who are medically unstable.
  • Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
  • Participants in whom PAP therapy is otherwise medically contraindicated.
  • Participants who are unwilling to wear CPAP
  • Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
  • 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 (PLM Arousal Index \> 15).
  • Participants who are unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72205, United States

Location

Mark G. Goetting

Portage, Michigan, 49024, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Sleepcare Diagnostics

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Central

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

Not all of the secondary analysis was completed as this study also captured engineering data which is not part of standard PSG scoring.

Results Point of Contact

Title
Shahrokh Javaheri, MD
Organization
Sleepcare Diagnostics
javaheri@snorenomore.com
513-459-7750

Study Officials

  • Jamie Goodwin

    University of Arizona

    PRINCIPAL INVESTIGATOR

  • Shahrokh Javaheri, MD

    Sleepcare Diagnostics

    PRINCIPAL INVESTIGATOR

  • Rami Khayat, MD

    Ohio State Univercity

    PRINCIPAL INVESTIGATOR

  • Mark Goetting, MD

    Sleep Health

    PRINCIPAL INVESTIGATOR

  • Paul Wylie, MD

    Arkansas Center for Sleep Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

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

July 18, 2008

First Posted

July 22, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 29, 2019

Results First Posted

January 29, 2019

Record last verified: 2019-01

Locations

US(5)