Trial · NCT02478580
Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
NCT02478580, Phase 3, Completed, University of Texas Southwestern Medical Center; results first posted 2016-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients. Trials, record NCT02478580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02478580
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients
- NCT number
- NCT02478580
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Obesity, Premature Recovery From Anesthesia
- Interventions
- Nuvigil, Placebo
- First posted
- 2015-06-23
- Last updated
- 2018-12-04
- Results first posted
- 2016-03-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Care Unit (PACU) Recovery Time | Immediate postoperative period (up to 3 hours) | Participants will be followed for the duration of PACU stay, an expected average of 3 hours. |
| Secondary | The Aldrete Score | 2 hours after extubation | Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Care Unit (PACU) Recovery Time | Immediate postoperative period (up to 3 hours) | Patient with obstructive sleep apnea undergoing surgery | Minutes | MEAN |
| SECONDARY | The Aldrete Score | 2 hours after extubation | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Care Unit (PACU) Recovery Time | Nuvigil | 98.2 | Standard Deviation 58.2 | Minutes | |
| Postoperative Care Unit (PACU) Recovery Time | Control | 95 | Standard Deviation 60.7 | Minutes | |
| The Aldrete Score | Nuvigil | 9.4 | Standard Error 0.27 | units on a scale | |
| The Aldrete Score | Placebo | 9.3 | Standard Error 0.26 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nuvigil | 34 | |
| Overall Study | STARTED | Control | 33 | |
| Overall Study | COMPLETED | Nuvigil | 34 | |
| Overall Study | COMPLETED | Control | 33 | |
| Overall Study | NOT COMPLETED | Nuvigil | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nuvigil | 0 | 34 |
| Total, all-cause mortality | Control | 0 | 33 |
| Total, other adverse events | Nuvigil | 0 | 34 |
| Total, other adverse events | Control | 0 | 33 |
| Total, serious adverse events | Nuvigil | 0 | 34 |
| Total, serious adverse events | Control | 0 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nuvigil vs Control: deaths from any cause | Trial comparisons |
| Nuvigil vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02478580
GET https://conductscience.org/api/trials/v1/NCT02478580/registered