Trial · NCT00883740
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Wake After Sleep Onset (WASO) at Weeks 5 and 11 | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET) | Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations; | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Wake Time During Sleep (WTDS) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Wake Time After Sleep (WTAS) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Total Sleep Time (TST) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Sleep Efficiency (SE) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Percentage of time asleep | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings After Sleep Onset (NAASO 1) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings After Sleep Onset (NAASO 2) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Latency to Persistent Sleep (LPS) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | WASO by Hour of the Night | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | WASO by Each Quarter of the Night | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Slow Wave Sleep (SWS) | Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET | ITT | Percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11 | Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET | ITT; n: number of participants at specific time points | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11 | Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET | ITT | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sleep Quality | Weeks 1, 2, 3 and 4 of Each Intervention Period or ET | ITT; Last observation carried forward (LOCF) | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Latency of Sleep Onset (LSO) | Weeks 1, 2, 3 and 4 of Each Intervention Period or ET | ITT; LOCF | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Pain Score | Daily up to Day 73 or ET | ITT; LOCF | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Wake After Sleep Onset (sWASO) | Weeks 1, 2, 3 and 4 of Each Intervention Period or ET | ITT; LOCF | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Total Sleep Time (sTST) | Weeks 1, 2, 3 and 4 of Each Intervention Period or ET | ITT; LOCF | Minutes | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00883740/outcomes