NCT01241604

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
29 days 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
1.4 years until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
8.4 years until next milestone

Results Posted

Study results publicly available

April 9, 2019

Completed
Last Updated

April 9, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

June 2, 2009

Results QC Date

January 9, 2019

Last Update Submit

March 15, 2019

Conditions

Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index

    The number of apneas and hypopneas per hour of sleep.

    2 nights

Secondary Outcomes (17)

  • Apnea Hypopnea Index- REM

    2 nights

  • Central Apnea Index

    2 nights

  • Obstructive Apnea Index

    2 nights

  • Mixed Apnea Index

    2 nights

  • Hypopnea Index

    2 nights

  • +12 more secondary outcomes

Study Arms (2)

Respironics BiPAP S/T

ACTIVE COMPARATOR

Control Arm using Respironics BiPAP S/T

Device: BiPAP S/T

Respironics BiPAP Auto SV3

ACTIVE COMPARATOR

Treatment arm using Respironics BiPAP Auto SV3

Device: BiPAP Auto SV3

Interventions

BiPAP S/TDEVICE

Mechanical Non-invasive Ventilation

Also known as: Respironics BiPAP S/T
Respironics BiPAP S/T
BiPAP Auto SV3DEVICE

Auto Servo Ventilation Device

Also known as: Respironics BiPAP auto SV Advanced
Respironics BiPAP Auto SV3

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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med One Medical Sleep Laboratory

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Jeremy Powers
Organization
Philips Respironics
jeremy.powers@philips.com
412-542-3669

Study Officials

  • Brydon Grant, MD

    Medical Director of Med One Medical

    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

June 2, 2009

First Posted

November 16, 2010

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 9, 2019

Results First Posted

April 9, 2019

Record last verified: 2019-03

Locations

US(1)