NCT02522442

Brief Summary

The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the continuous positive airway pressure (CPAP) group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly greater than that for all participants in the CPAP therapy arm

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

3 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

August 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

July 18, 2011

Results QC Date

January 22, 2019

Last Update Submit

April 25, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use.

    Compliance was compared between the AutoBiLevel Group and the CPAP group by measuring the average use per night over the study period.

    90 days

  • Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group

    Percentage of Group Compliance was compared between AutoBiLevel Group and the CPAP group by measuring proportion of adherent users over the treatment period. Patients with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The % of compliant patients will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each subject.

    90 days

Secondary Outcomes (3)

  • Epworth Sleepiness Scale

    Assessed at Baseline, Day 30 and Day 90

  • Fatigue Severity Scale

    Assessed at Baseline, Day 30 and Day 90

  • Functional Outcomes of Sleep Quality

    Assessed at Baseline, Day 30 and Day 90

Study Arms (2)

Auto BiLevel Group

EXPERIMENTAL

Auto Bilevel; auto-titrating bilevel positive airway pressure device with pressure flexing used as experimental treatment for obstructive sleep apnea

Device: Auto BiLevel

CPAP Group

ACTIVE COMPARATOR

CPAP; continuous positive airway pressure used as comparator treatment for obstructive sleep apnea

Device: CPAP

Interventions

CPAPDEVICE

Continuous positive airway pressure

CPAP Group
Auto BiLevelDEVICE

Auto Bilevel positive airway pressure with Flex

Auto BiLevel Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Participation in another interventional research study within the last 30 days
  • Major uncontrolled medical or psychiatric condition such as congestive heart failure, neuromuscular disease, renal failure etc.
  • Prior CPAP or Bi-Level PAP use (within last 2 years)
  • Chronic respiratory failure or insufficiency, moderate Chronic Obstructive Pulmonary Disease (COPD) (FEV1 \< 60%), or any known condition of an elevation of arterial carbon dioxide levels while awake
  • Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
  • Presence of an untreated, diagnosable, non-OSA related sleep disorder (e.g. restless legs syndrome, insomnia, etc.)
  • Periodic Limb movement arousal index of 10 or greater.
  • Refusal to consider further interventions to standard CPAP to optimize positive pressure therapy (e.g. different mask than what was used in lab)
  • PAP therapy otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks
  • Shift workers or people experiencing jet lag
  • Known history of alcohol and or drug abuse
  • Diagnosis of Complex Sleep Apnea, (appears to be classic obstructive or mixed sleep apnea, but exhibits disruptive central apneas and periodic breathing on CPAP) 11, 12 or persistent central apnea during diagnostic PSG.
  • Diagnosis of Attention Deficit Hyperactivity Disorder
  • Chronic Hypnotic use (nightly use for three months or less)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinics

Rochester, Minnesota, 55905, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Related Publications (1)

  • Powell ED, Gay PC, Ojile JM, Litinski M, Malhotra A. A pilot study assessing adherence to auto-bilevel following a poor initial encounter with CPAP. J Clin Sleep Med. 2012 Feb 15;8(1):43-7. doi: 10.5664/jcsm.1658.

    PMID: 22334808RESULT

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
Eric Powell, Ph.D.
Organization
Sleep Therapy & Research Center
powell.eric@sleeptrc.com
(210) 614-6000

Study Officials

  • Eric Powell, Ph.D.

    Philips Respironics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

August 13, 2015

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 26, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-04

Locations

US(3)