Trial · NCT01280591
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Wake Time After Sleep Onset (WASO) Measured by Actigraphy | Up to 10 hours | WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. |
| Primary | Sleep Latency Measured by Actigraphy | Up to 10 hours | Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. |
| Secondary | Total Sleep Time Measured by Actigraphy | Up to 10 hours | Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. |
| Secondary | Sleep Efficiency Measured by Actigraphy | Up to 10 hours | Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. |
| Secondary | Global Assessment of Investigational Product as a Sleep Aid | Up to 10 hours | The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). |
| Secondary | Karolinska Sleep Diary - Sleep Quality | Up to 10 hours | Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) |
| Secondary | Karolinska Sleep Diary - Calmness of Sleep | Up to 10 hours | Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) |
| Secondary | Karolinska Sleep Diary - Easiness to Fall Asleep | Up to 10 hours | Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) |
| Secondary | Karolinska Sleep Diary - Premature Awakening | Up to 10 hours | Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) |
| Secondary | Karolinska Sleep Diary - Ease of Awakening | Up to 10 hours | Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) |
| Secondary | Karolinska Sleep Diary - Well Rested | Up to 10 hours | Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) |
| Secondary | Karolinska Sleep Diary - Sufficient Sleep | Up to 10 hours | Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) |
| Secondary | Subjective Sleep Questionnaire - Quality of Your Sleep Last Night | Up to 10 hours | Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent) |
| Secondary | Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night | Up to 10 hours | Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) |
| Secondary | Subjective Sleep Questionnaire - Time to Fall Asleep Last Night | Up to 10 hours | Subjects responded to Estimate of how long it took to fall asleep (minutes) |
| Secondary | Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed | Up to 10 hours | Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) |
| Secondary | Change From Baseline in Pain Intensity | Baseline and up to 10 hours | Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain |
| Secondary | Overall Rating of Pain Relief | Up to 10 hours | The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement "Overall, the relief from my starting pain was": no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4). |
| Secondary | Time to Rescue Medication | Up to 10 hours | If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded |
| Secondary | Cumulative Proportion of Subjects Taking Rescue Medication by Hour | Up to 10 hours | If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded |
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/NCT01280591/registered