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View Clinical Trial (Medical Research Study)
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Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness - NCT00393913-10016 (Clinical Trial 154408)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy154408.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10016 |
| Conditions: |
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Sleep Apnea, Obstructive |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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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| Study is available at: |
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NYU Sleep Disorders Center
New York, NY 10016
United States
Primary Contact:
Bien Pagan Lee
Email: bien.pagan@med.nyu.edu
Phone: 212-263-7130 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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