Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089752
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2004-08-12
Brief Title:
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea CATNAP
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATNAP
Brief Summary:
The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea OSA following continuous positive airway pressure CPAP treatment
Detailed Description:
BACKGROUND
OSA is characterized as mild moderate or severe according to the number of respiratory disturbances per hour of sleep RDI as defined by the American Academy of Sleep Medicine CPAP is the primary treatment for sleep apnea The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied There is evidence from randomized controlled studies that CPAP also improves functional status and the key manifestation of OSA including excessive daytime sleepiness in individuals with severe OSI ie RDI greater than 30 However there has been limited research exploring improvement in functional status in individuals with less severe OSA ie those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30 The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies evaluating the true impact of this treatment Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal principally because of serious methodological limitations It remains unclear whether CPAP treatment improves daily functioning in those with milder OSA RDI 5-30 This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15 of the US population
DESIGN NARRATIVE
Using Grangers model of functional assessment this study will examine whether functional status improves in participants with milder OSA following CPAP treatment The study will employ a randomized placebo-controlled parallel study design and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness The study will test the hypothesis that the change in functional status measured by the Functional Outcomes of Sleep Questionnaire after 8 weeks of treatment will be greater for participants treated with active CPAP compared to the placebo Secondary aims of the study include examining whether CPAP also improves daytime sleepiness and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA
OSA is characterized as mild moderate or severe according to the number of respiratory disturbances per hour of sleep RDI as defined by the American Academy of Sleep Medicine CPAP is the primary treatment for sleep apnea The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied There is evidence from randomized controlled studies that CPAP also improves functional status and the key manifestation of OSA including excessive daytime sleepiness in individuals with severe OSI ie RDI greater than 30 However there has been limited research exploring improvement in functional status in individuals with less severe OSA ie those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30 The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies evaluating the true impact of this treatment Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal principally because of serious methodological limitations It remains unclear whether CPAP treatment improves daily functioning in those with milder OSA RDI 5-30 This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15 of the US population
DESIGN NARRATIVE
Using Grangers model of functional assessment this study will examine whether functional status improves in participants with milder OSA following CPAP treatment The study will employ a randomized placebo-controlled parallel study design and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness The study will test the hypothesis that the change in functional status measured by the Functional Outcomes of Sleep Questionnaire after 8 weeks of treatment will be greater for participants treated with active CPAP compared to the placebo Secondary aims of the study include examining whether CPAP also improves daytime sleepiness and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076101 | NIH | None | httpsreporternihgovquickSearchR01HL076101 |