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NCT02478580 · ClinicalTrials.gov registry record · Phase 3
Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT02478580: Completed Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT02478580 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02478580, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative morbidity and mortality. This group of patients is at risk of perioperative desaturations which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA patients might also need to spend the night in intensive care for more frequent monitoring for any desaturations episodes especially if the patient will be requiring multiple intravenous narcotic boluses for pain control. Several studies have looked into the most appropriate way to manage these patients and some recommendations have been made to avoid outpatient surgery with close monitoring for first 24 hours after surgery specifically if patient will require intravenous postoperative narcotics. Nuvigil (Armodafinil) is a wake promoting agent (Cephalon inc., West Chester, PA) that's FDA approved for excessive daytime sleepiness in narcolepsy, shift work sleep disorder, and obstructive sleep apnea. The precise mechanism(s) through which armodafinil (R-enantiomer) or modafinil (mixture of R- and S-enantiomers) promote wakefulness is unknown. Nuvigil is longer acting product which is similar in action to Modafinil however is much cheaper. Nuvigil has not been previously studied for postoperative recovery. The investigators intend to study the effects of Nuvigil on postoperative recovery time and wakefulness in obstructive sleep apnea and obese patients.
Primary Outcome
Participants will be followed for the duration of PACU stay, an expected average of 3 hours.
Interventions
- DRUG Placebo
- DRUG Nuvigil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT02478580 record still lists
NCT02478580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02478580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02478580 about?
NCT02478580 is a clinical study titled "Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients". Obstructive sleep apnea (OSA) and obesity is associated with increased perioperative morbidity and mortality. This group of patients is at risk of perioperative desaturations which can be worsened by perioperative sedatives and narcotics needed for surgery. OSA patients might also need to spend the ...
What is the current status of trial NCT02478580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2011-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02478580?
The interventions under investigation include: Placebo (DRUG), Nuvigil (DRUG).
Who is sponsoring clinical trial NCT02478580?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02478580's enrollment target sits among peer trials
67 1796th of 2000 higher than 204 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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