Trial · NCT02424695
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The mean change from baseline to week 4 in intensity of cortical arousals associated with periodic limb movements (PLMs) | 4 weeks | Cortical EEG arousals will be scored using wavelet analysis of C3/A2 and C4/A1 EEG signals. Arousals scored in NREM sleep will be assigned a score from 0-9. This arousal scaling is entirely subjective. Wavelet analysis will be performed on each of the scaled arousals using wavelet features that correlate with arousal intensity. The arousal intensity will be measured using Wavelet Transform which is superior for analyzing signals such as EEG. |
| Secondary | The mean change from baseline to week 4 in heart rate variability associated with arousals secondary to periodic limb movements (PLMs) | 4 weeks | Beat to beat heart rate measurement will identify the highest value in the interval 2-12 seconds preceding each arousal which will be used as a baseline heart rate. The highest heart rate in the interval between arousal and at 8 seconds after its end, and the difference from baseline will represent the change in heart rate associated with the arousal. |
| Secondary | The mean change from baseline to week 4 in blood pressure associated with arousals secondary to periodic limb movements (PLMs) | 4 weeks | Blood pressure changes will be identified using the same technique as the heart rate changes. Continuous blood pressure will be monitored using Somnotouch RESP. Using the 2-12 seconds preceding each arousal, any identified change between onset of arousal and at 8 seconds after its end will represent the change in blood pressure. |
| Secondary | The mean change from baseline to week 4 in periodic limb movement (PLM) intensity | 4 weeks | Periodic limb movement (PLM) intensity will be derived by measuring the highest anterior tibialis EMG amplitude during the 2-12 seconds prior to arousal onset and comparing to maximum EMG amplitude during PLMs with or without associated arousal. |
| Secondary | The mean change from Baseline to week 4 in Rechtschaffen and Kales polysomnography parameters | 4 weeks | Polysomnography (PSG) studies will be recorded for 8 hours using standard techniques described by Rechtschaffen and Kales (R\&K). The R\&K standard PSG parameters include: Total sleep time (TST), wake after sleep onset (WASO), latency to persistent sleep (LPS 10), sleep efficiency (SE), number of awakenings per hour of sleep (Awakenings Index), arousals index (AI), sleep stage percentages, periodic limb movements per hour (PLMI), and periodic limb movements associated with arousal per hour (PLMAI). |
| Secondary | The mean change from baseline to week 4 in International Restless Legs Syndrome (IRLS) Rating Scale total score | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in proportion of responders ("much"/ "very much" improved) on the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in proportion of responders ("moderately better" to "a great deal better") on the patient Global Impression of Change (PGIC) scale | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Post Sleep Questionnaire (PSQ)scores | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Subjective Sleep Questionnaire (SSQ) scores | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL) scores | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in Restless Legs Syndrome- Next Day Impact Questionnaire (RLS-NDI) scores | 4 weeks | |
| Secondary | The mean change from Baseline to week 4 in the Epworth Sleepiness Scale (ESS) scores | 4 weeks | |
| Secondary | Number of subjects with treatment emergent adverse events | 4 weeks | |
| Secondary | Number of subjects with mild, moderate and severe adverse events | 4 weeks |
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.
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