Trial · NCT01048242
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
NCT01048242, Phase 3, Completed, University of Pennsylvania; results first posted 2017-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375). Trials, record NCT01048242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01048242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
- NCT number
- NCT01048242
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Insomnia, Obstructive Sleep Apnea
- Interventions
- rozerem, Placebo
- First posted
- 2010-01-13
- Last updated
- 2023-05-25
- Results first posted
- 2017-05-03
- Limitations and caveats
Auto-Continuous Positive Airway Pressure units used. Single-night of polysomnography Unequal sized arms despite randomization Low rate of completion of at-home sleep diaries Small sample size (pilot study)
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep Onset Latency | 4 weeks | Time to sleep onset as determined by polysomnography |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sleep Onset Latency | 4 weeks | analysis per protocol | minutes | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sleep Onset Latency | Ramelteon | 9.7 | Standard Deviation 10.3 | minutes | |
| Sleep Onset Latency | Sugar Pill | 34.4 | Standard Deviation 30.7 | minutes |
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 | Ramelteon | 12 | |
| Overall Study | STARTED | Sugar Pill | 15 | |
| Overall Study | COMPLETED | Ramelteon | 8 | |
| Overall Study | COMPLETED | Sugar Pill | 13 | |
| Overall Study | NOT COMPLETED | Ramelteon | 4 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 2 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin ulcer | Skin and subcutaneous tissue disorders | Ramelteon | 1 | 8 | 1 |
| other | Skin ulcer | Skin and subcutaneous tissue disorders | Sugar Pill | 0 | 13 | 0 |
| other | Paranasal sinusitis | Respiratory, thoracic and mediastinal disorders | Ramelteon | 1 | 8 | 1 |
| other | Paranasal sinusitis | Respiratory, thoracic and mediastinal disorders | Sugar Pill | 0 | 13 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Ramelteon | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Sugar Pill | 0 | 13 | 0 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Ramelteon | 1 | 8 | 1 |
| other | Fracture | Musculoskeletal and connective tissue disorders | Sugar Pill | 0 | 13 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ramelteon | 0 | 8 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Sugar Pill | 1 | 13 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramelteon | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Ramelteon | 4 | 8 |
| Total, other adverse events | Sugar Pill | 2 | 13 |
| Total, serious adverse events | Ramelteon | 0 | 8 |
| Total, serious adverse events | Sugar Pill | 0 | 13 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ramelteon vs Sugar Pill: serious adverse events |
Source 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/NCT01048242
GET https://conductscience.org/api/trials/v1/NCT01048242/registered