NCT01450540

Brief Summary

Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

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

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

October 7, 2011

Results QC Date

October 19, 2020

Last Update Submit

February 10, 2021

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • CPAP Adherence

    Device usage (hours per night)

    3 months

Secondary Outcomes (2)

  • Functional Outcome Sleep Quality (FOSQ)

    3 months

  • Daytime Sleepiness as Measured by the Epworth Sleepiness Scale

    3 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

REMStar auto A-Flex

Device: REMstar Auto A-Flex

Group 2

EXPERIMENTAL

modified REMstar Auto A-Flex with AGPAP

Device: modified REMstar Auto A-Flex with AGPAP

Interventions

REMstar Auto A-FlexDEVICE

Standard CPAP

Also known as: Philips Respironics System One
Group 1
modified REMstar Auto A-Flex with AGPAPDEVICE

Modified device -Software upgrade to GP 12

Also known as: Philips Respironics System One
Group 2

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed with OSA (last 12 weeks)
  • Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O
  • Willing and able to provide informed consent
  • Able to follow instructions

You may not qualify if:

  • Participation in another interventional research study within the last 30 days
  • Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
  • Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.
  • Prescribed BiLevel therapy
  • Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia)
  • History of an automobile accident or near accident in the last 12 months due to sleepiness.
  • Severe oxygen desaturation on the PSG (Sa02 \< 70% for 10% of the diagnostic PSG study).
  • Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days
  • Regular use (\>3 nights per week) of sleeping pills or stimulants.
  • Currently working a night shift or rotating day/night shift.
  • Unwillingness to try PAP at home.
  • Presence of tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Delta Waves Sleep Disorder and Research Center

Colorado Springs, Colorado, 80918, United States

Location

Sleep Disorders Center of Georgia

Atlanta, Georgia, 30342, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Senior Data Scientist
Organization
Philips
+14125423651

Study Officials

  • Alan Lankford, PhD

    Sleep Disorders Center of Georgia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 12, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 3, 2021

Results First Posted

March 3, 2021

Record last verified: 2021-02

Locations

US(5)