Trial · NCT02691013
The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
NCT02691013, Not applicable, Unknown, University of California, San Diego; results first posted 2019-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery. Trials, record NCT02691013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02691013
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
- NCT number
- NCT02691013
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 120 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Delirium, Sleep Deprivation
- Interventions
- Ramelteon, Placebo
- First posted
- 2016-02-24
- Last updated
- 2022-02-08
- Results first posted
- 2019-09-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Delirium | Twice daily for up to 10 days | Measured twice daily during the ICU stay using the Confusions Assessment Method instrument. |
| Primary | Total Duration of Sleep | Daily for up to 10 days | Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time. |
| Secondary | Number of Participants With Delirium | Twice daily for up to 10 days | Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument |
| Secondary | Average Daily Critical Care Pain Observation Tool (CPOT) | 10 days | average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation. |
| Secondary | Length of Hospital Stay | Duration of hospital admission | |
| Secondary | Length of ICU Stay | Duration of hospital admission | |
| Secondary | Measures of Light Quality in the Patient's Room | 3 days | Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes. |
| Secondary | Measures of the Sound Levels in the Patient's Room | 3 days | Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Delirium | Twice daily for up to 10 days | hours | MEDIAN | |
| PRIMARY | Total Duration of Sleep | Daily for up to 10 days | Due to funding \& logistical constraints, only a subset of subjects would've been able to do the electroencephalography (EEG) monitoring used for sleep assessment. Thus, Total Duration of Sleep was not measured and we focused on our a priori secondary outcome of incident delirium, a change made before the start of data collection or analysis. | ||
| SECONDARY | Number of Participants With Delirium | Twice daily for up to 10 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Average Daily Critical Care Pain Observation Tool (CPOT) | 10 days | |||
| SECONDARY | Length of Hospital Stay | Duration of hospital admission | days | MEDIAN | |
| SECONDARY | Length of ICU Stay | Duration of hospital admission | days | MEDIAN | |
| SECONDARY | Measures of Light Quality in the Patient's Room | 3 days | |||
| SECONDARY | Measures of the Sound Levels in the Patient's Room | 3 days |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Delirium | Placebo | 16 | Inter-Quartile Range 10 to 29 | hours | |
| Duration of Delirium | Ramelteon | 24 | Inter-Quartile Range 14 to 37 | hours | |
| Number of Participants With Delirium | Placebo | 22 | Participants | ||
| Number of Participants With Delirium | Ramelteon | 19 | Participants | ||
| Length of Hospital Stay | Placebo | 12 | Inter-Quartile Range 10 to 14 | days | |
| Length of Hospital Stay | Ramelteon | 12 | Inter-Quartile Range 10 to 16 | days | |
| Length of ICU Stay | Placebo | 4 | Inter-Quartile Range 3 to 5 | days | |
| Length of ICU Stay | Ramelteon | 4 | Inter-Quartile Range 3 to 6 | days |
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 | Placebo | 61 | |
| Overall Study | STARTED | Ramelteon | 59 | |
| Overall Study | COMPLETED | Placebo | 58 | |
| Overall Study | COMPLETED | Ramelteon | 59 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Ramelteon | 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 | Placebo | 4 | 61 |
| Total, all-cause mortality | Ramelteon | 3 | 59 |
| Total, other adverse events | Placebo | 0 | 61 |
| Total, other adverse events | Ramelteon | 0 | 59 |
| Total, serious adverse events | Placebo | 0 | 61 |
| Total, serious adverse events | Ramelteon | 0 | 59 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramelteon vs Placebo: Number of Participants With Delirium | Trial comparisons |
| Ramelteon vs Placebo: deaths from any cause | Trial comparisons |
| Ramelteon vs Placebo: 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/NCT02691013
GET https://conductscience.org/api/trials/v1/NCT02691013/registered