An interventional study of Continuous positive airway pressure and Auto-adjusting positive airway pressure treatment in Obstructive Sleep Apnea, sponsored by North Florida Foundation for Research and Education. Completed at 1 site in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2014-11-03.
Sponsored by North Florida Foundation for Research and Education · Not applicable, Interventional, and Treatment
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
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 156 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →North Florida Foundation for Research and Education is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
continuous positive airway pressure determined by polysomnography titration
Also known as: CPAP
Pressure range 4-18 centimeters of water (cm H2O)
Also known as: AutoCPAP, APAP
Positive Airway Pressure Adherence (Nightly Use of Treatment)
average nightly hours of using positive airway pressure (including 0 for nights not used)
Time frame: 6 weeks after starting treatment
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.
Time frame: 6 weeks after starting treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks clinic
| Milestone | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Started | 78 | 78 |
| Cpap titration | 78 | 78 |
| Pap setup | 70 | 78 |
| Clinic visit | 64 | 69 |
| Using cpap or apap | 59 | 66 |
| Completed | 59 | 66 |
| Not completed | 19 | 12 |
| Withdrew: Withdrawal by subject | 8 | 0 |
| Withdrew: Lost to follow-up | 6 | 9 |
| Withdrew: Not using cpap | 5 | 3 |
average nightly hours of using positive airway pressure (including 0 for nights not used)
| hours | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Positive Airway Pressure Adherence (Nightly Use of Treatment) | 3.99 ± 2.3 | 4.45 ± 2.3 |
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.
| units on a scale | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Change in Epworth Sleepiness Scale | -3.7 ± 4.8 | -4.1 ± 4.7 |
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.
| units on a scale | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Change in Functional Outcomes of Sleep Questionnaire | 2.2 ± 3.7 | 2.6 ± 3.5 |
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.
| events (apneas+hypopneas)/hour | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Residual Apnea-hypopnea Index | 4.9 ± 4.9 | 5.5 ± 4.7 |
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.
| cm H2O | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| Treatment Pressure (Level of CPAP or 90th Percentile APAP) | 11.7 ± 2.5 | 10.8 ± 3.1 |
Collected over Study duration. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | — | 0/78 (0%) | 19/78 (24.4%) |
| Auto-Adjusting Positive Airway Pressure | — | 0/78 (0%) | 12/78 (15.4%) |
| Event | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure |
|---|---|---|
| PAP treatment intoleranceGeneral disorders | 19/78 | 12/78 |
Apnea+hypopnea index \>= 10/hour
| Age, Continuous(years) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| Mean | 61.5 ± 11.9 | 58.3 ± 12.0 | 58.7 ± 12.4 |
| Sex: Female, Male(Participants) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 72 | 73 | 145 |
| Race (NIH/OMB)(Participants) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 22 | 41 |
| White | 59 | 56 | 115 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| United States | 78 | 78 | 156 |
| Body mass index(kg/m^2) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| Mean | 34.9 ± 6.0 | 34.2 ± 5.8 | 34.6 ± 5.9 |
| apnea+hypopnea index(number of apneas and hypopneas /hour) | PSG CPAP Titration Then CPAP Treatment | Auto-Adjusting Positive Airway Pressure | Total |
|---|---|---|---|
| Mean | 31.0 ± 19.1 | 28.6 ± 18.2 | 29.8 ± 18.6 |
The record gives a start of Feb 2010, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2014, 1 year 11 months after primary completion.
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North Florida Foundation for Research and Education