Improving Outcomes for Patients With SDB and Insufficient Sleep

Summary

Participation Requirements

Description

Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. A significant proportion of the populace has mild SDB. This study is a randomized control trial (R...

Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. A significant proportion of the populace has mild SDB. This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measure will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index between 5 and 15, and who meet all inclusion/exclusion criteria will be randomized to one of three educational programs. All groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months. Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for clinical trials.

Tracking Information