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Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness - NCT00393913-10016(Clinical Trial 154408)



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City:  New York
State:  
NY
Zip Code: 10016
Conditions: Sleep Apnea, Obstructive
Purpose: Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing, or experiences shallow breathing for short periods of time during sleep. Daytime sleepiness is a common symptom of OSA and may affect an individual's level of alertness throughout the day. The purpose of this study is to evaluate the relationship between sleep-disordered breathing and levels of daytime alertness in individuals being treated with a continuous positive airway pressure (CPAP) machine, a common treatment for OSA.
Study summary: Individuals with OSA can experience up to 300 sleep disruptions each night, which may result in excessive daytime sleepiness (EDS), one of the most common symptoms of OSA. EDS can have serious consequences, including motor vehicle accidents, poor school performance, and work-related accidents and performance issues. The most common treatment for OSA is CPAP therapy. This involves wearing a mask over the nose while sleeping; air then flows through the mask into the nose to maintain a level of pressure that keeps the breathing passages open. CPAP therapy typically results in fewer sleep and breathing disruptions during the night, which may increase an individual's alertness levels during the day. The purpose of this study is to evaluate the relationship between sleep-disordered breathing and daytime alertness levels in adults with symptoms of OSA who are receiving CPAP therapy. This study will involve three to five study visits over a 2- to 3-month period. During the first 3 days, participants will record their sleep habits in a diary and will wear a device that measures breathing, oxygen levels, and sleep position. All participants will then take part in a 1-night inpatient stay at the sleep center lab during which brain, eye, muscle, heart, and breathing activity will be monitored. Participants with a confirmed diagnosis of OSA will stay at the sleep lab one additional night for observation while using a CPAP machine. The following day, tests to measure alertness, ease of falling asleep, and sleepiness levels will be administered. Participants will then use the CPAP machine at home for 4 weeks; each machine will be set at an appropriate level for the participant, and will record breathing patterns and pressure. Participants will receive weekly phone calls for monitoring purposes. At the end of Week 4, participants will return to the sleep lab for one additional night of CPAP monitoring, followed by alertness and sleep testing. Those with severe OSA will use the CPAP machine at a newly adjusted level for 5 additional days and return for repeat testing. All participants will use CPAP for 2 final weeks, and will return to the lab for overnight sleep testing without the CPAP machine and for alertness testing.
Criteria: Inclusion Criteria: - Experiences symptoms of OSA, including snoring and sleepiness - Stable medical history with no change in medications that could affect sleepiness Exclusion Criteria: - Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome) - Medically unstable health conditions (e.g., heart attack, congestive heart failure) - Use of psychotropic medications that cause sedation in the 3 months prior to study entry - Recent or confirmed history of recreational drug use or alcohol abuse - Pregnant - Inability to communicate verbally, write, or read - Visual, hearing, or cognitive impairment
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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