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NCT01753999 · ClinicalTrials.gov registry record · NA
Obstructive Sleep Apnea in World Trade Center Responders
A NA study of Obstructive Sleep Apnea, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 317
- Enrollment target
- 3
- Study locations
NCT01753999: Completed NA study of Obstructive Sleep Apnea, sponsored by Rutgers, The State University of New Jersey.
NCT01753999 is a NA study of Obstructive Sleep Apnea that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 317 participants, above the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (44% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753999, a NA study of Obstructive Sleep Apnea, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 317 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, the study will look at upper airway disease (problems with the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow through the nose). Subjects will have a physical exam and answer questions about nasal symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry (measuring the airflow through the nose) will also be performed to measure the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure) device. This device blows air into a mask worn by the patient during sleep. The two treatment methods that will be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be randomly assigned to one treatment method for one month then crossed to the other treatment method for the next month. The investigators will determine if patients with certain nasal conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.
Primary Outcome
The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover).
Conditions Studied
Interventions
- DEVICE Standard CPAP
- DEVICE CPAP - Flex
Study Locations (3)
New York
- New York University School of Medicine Clinical Center of Excellence - New York
- Mount Sinai School of Medicine - New York
New Jersey
- Environmental and Occupational Health Sciences Institute - Piscataway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-03 |
| Phase | NA |
What the finished NCT01753999 record still lists
NCT01753999 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, above the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (44% higher).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Standard CPAP is the first listed.
NCT01753999 reports a single indexed study location in New York, New Jersey.
Frequently Asked Questions
What is clinical trial NCT01753999 about?
NCT01753999 is a clinical study titled "Obstructive Sleep Apnea in World Trade Center Responders". The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, t...
What is the current status of trial NCT01753999?
This trial is currently completed. It is a NA study. The enrollment target is 317 participants. The study started on 2012-12. Estimated completion is 2017-03.
What conditions does trial NCT01753999 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT01753999?
The interventions under investigation include: Standard CPAP (DEVICE), CPAP - Flex (DEVICE).
Who is sponsoring clinical trial NCT01753999?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01753999 being conducted?
This trial has 3 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01753999's enrollment target sits among peer trials
317 22nd of 155 higher than 134 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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