Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
|ClinicalTrials.gov Identifier: NCT00988351|
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : November 3, 2014
Last Update Posted : November 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Continuous positive airway pressure Device: Auto-adjusting positive airway pressure treatment||Not Applicable|
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.
METHODS: Study visits:
Before informed consent (routine clinical care)
- Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.
- Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria
After informed consent
- PM study
- Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic.
- PSG for CPAP titration (PSG arm only).
- CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes.
- Telephone contact within 7 days of setup with early intervention for PAP problems if needed.
- Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: PSG CPAP titration then CPAP treatment
Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment
Device: Continuous positive airway pressure
continuous positive airway pressure determined by polysomnography titration
Other Name: CPAP
Active Comparator: Auto-Adjusting Positive Airway Pressure
Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.
Device: Auto-adjusting positive airway pressure treatment
Pressure range 4-18 centimeters of water (cm H2O)
- Positive Airway Pressure Adherence (Nightly Use of Treatment) [ Time Frame: 6 weeks after starting treatment ]average nightly hours of using positive airway pressure (including 0 for nights not used)
- Change in Epworth Sleepiness Scale [ Time Frame: 6 weeks after starting treatment ]Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.
- Change in Functional Outcomes of Sleep Questionnaire [ Time Frame: 6 weeks at clinic ]The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.
- Residual Apnea-hypopnea Index [ Time Frame: over first 6 weeks of treatment ]The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.
- Treatment Pressure (Level of CPAP or 90th Percentile APAP) [ Time Frame: 6 weeks clinic ]The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988351
|United States, Florida|
|Malcom Randall VA Medical Center|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Richard B Berry, MD||University of Florida/Malcom Randall VAMC|