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The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.
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)
After informed consent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSG CPAP titration then CPAP treatment | Active Comparator | 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 |
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| Auto-Adjusting Positive Airway Pressure | Active Comparator | Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | continuous positive airway pressure determined by polysomnography titration |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive Airway Pressure Adherence (Nightly Use of Treatment) | average nightly hours of using positive airway pressure (including 0 for nights not used) | 6 weeks after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale | 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. | 6 weeks after starting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Berry, MD | University of Florida/Malcom Randall VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Auto-adjusting positive airway pressure treatment | Device | Pressure range 4-18 centimeters of water (cm H2O) |
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| Change in Functional Outcomes of Sleep Questionnaire | 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. | 6 weeks at clinic |
| Residual Apnea-hypopnea Index | 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. | over first 6 weeks of treatment |
| Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 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. | 6 weeks clinic |
| FG001 |
| Auto-Adjusting Positive Airway Pressure |
Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O) |
| CPAP Titration |
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| PAP Setup |
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| Clinic Visit |
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| Using CPAP or APAP |
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| COMPLETED |
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| NOT COMPLETED |
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Apnea+hypopnea index >= 10/hour
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration |
| BG001 | Auto-Adjusting Positive Airway Pressure | Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | measure weight and height compute as kg divided by height squared | Mean | Standard Deviation | kg/m^2 |
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| apnea+hypopnea index | AHI from Home sleep apnea test | Mean | Standard Deviation | number of apneas and hypopneas /hour |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Positive Airway Pressure Adherence (Nightly Use of Treatment) | average nightly hours of using positive airway pressure (including 0 for nights not used) | patients using cpap or apap at clinic visit | Posted | Mean | Standard Deviation | hours | 6 weeks after starting treatment |
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| Secondary | Change in Epworth Sleepiness Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks after starting treatment |
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| Secondary | Change in Functional Outcomes of Sleep Questionnaire | 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. | Using PAP 1/2 hour or more nightly | Posted | Mean | Standard Deviation | units on a scale | 6 weeks at clinic |
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| Secondary | Residual Apnea-hypopnea Index | 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. | participants using PAP at clinic visit (>= 1/2 hour of nightly use) | Posted | Mean | Standard Deviation | events (apneas+hypopneas)/hour | over first 6 weeks of treatment |
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| Secondary | Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 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. | participants using PAP at the 6 weeks clinic visit | Posted | Mean | Standard Deviation | cm H2O | 6 weeks clinic |
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Study duration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration | 0 | 78 | 19 | 78 | ||
| EG001 | Auto-Adjusting Positive Airway Pressure | Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O) | 0 | 78 | 12 | 78 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PAP treatment intolerance | General disorders | PAP intolerance | Non-systematic Assessment | unable to use PAP |
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Carefully selected group with male predominance
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard B. Berry | Malcom Randall VA | 3522621575 | Richard.Berry@medicine.ufl.edu |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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