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Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter

NCT00635206 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2009-07-14

No results posted yet for this study

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 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 arm is significantly greater than that for all participants in the CPAP therapy arm.

Secondary Measures

The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include:

* Hours of use per night, for all nights
* Hours of use per night, for nights with therapy use
* Device derived AHI
* Heart Rate Variability
* Functional Outcomes of Sleep Questionnaire (FOSQ),
* 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy,
* Epworth Sleepiness Scale (ESS) questionnaire
* Psychomotor Vigilance Task
* Attitudes toward use
* Actigraphy (sleep continuity) and sleep diary
* Fatigue Severity Scale
* Daytime Functioning Scale

Conditions

Interventions

DEVICE

BiPap auto with Fi Flex

* MinEPAP = 4 cmH2O for prescribed CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP \> 10 cmH2O) * MaxIPAP = 25 cm H2O * MinPS = 2 cm H2O (cannot be adjusted) * MaxPS = 8 cm H2O * Bi-Flex setting of 3

DEVICE

Standard CPAP

CPAP ≤ 10 cmH2O (use 6 cmH2O for prescribed CPAP \> 10 cmH2O)

Sponsors & Collaborators

  • Clayton Sleep Insititute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635206 on ClinicalTrials.gov