Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393913
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2006-10-30
Brief Title:
Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Relating Sleep Disordered Breathing to Daytime Function
Status:
COMPLETED
Status Verified Date:
2016-08
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:
None
Brief Summary:
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 individuals level of alertness throughout the day The primary purpose of this study is to evaluate the relationship between the severity of sleep-disordered breathing and levels of daytime alertness at baseline untreated state in a group of subjects with and without sleep apnea In addition the change in daytime sleepiness in subjects with sleep apnea being treated with a continuous positive airway pressure CPAP machine a common treatment for OSA will also be assessed
Detailed Description:
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 individuals alertness levels during the day The purpose of this study is to evaluate the relationship between severity of sleep-disordered breathing and daytime alertness levels in adults with and withoutout symptoms of OSA
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 4-6 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 who have been compliant with CPAP will return to the lab for overnight sleep testing without the CPAP machine and for alertness testing
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 4-6 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 who have been compliant with CPAP will return to the lab for overnight sleep testing without the CPAP machine and for alertness testing
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 |
|---|---|---|---|
| R01HL081310-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL081310-01A1 |