Trial · NCT04932096
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep Disturbances Scale for Children | 1-month | Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis. |
| Primary | Recruitment | through study completion, an average of 6-months | Quantitative number of patients consented per patients approached |
| Primary | Retention | through study completion, an average of 30 days | Quantitative number of participants completing trial procedures per patients consented |
| Secondary | Adherence Quantitative | 1-month | pill counts, report of using study medication at least 5/7 days per week |
| Secondary | Adherence Qualitative | 1-month | participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention |
| Secondary | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | 1-month | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue using a likert scale. Responses to each question receive a score of 0, 25,50,75, or 100. The measure provides a total score and three subscale scores- General, Sleep/rest, and Cognitive fatigue subscales based on the average response to each question for the total score and the average response to each subscale's questions for the subscale scores. All scores (total and subscale) range 0-100 with higher scores indicating better function and less fatigue. |
| Secondary | Chronotype | 1-month | Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness) |
| Secondary | Sleep Latency | 1-month | actigraphy measured time in minutes to fall asleep |
| Secondary | Total Sleep Time | 1-month | actigraphy measured total time asleep in minutes |
| Secondary | Wake After Sleep Onset | 1-month | actigraphy measured time in minutes awake after sleep onset |
| Secondary | Number of Night Awakenings | 1-month | actigraphy measured number of instances awoken after sleep onset |
| Secondary | Sleep Efficiency | 1-month | actigraphy measure percentage of nighttime period spent asleep |
| Secondary | Sleep Onset Time | 1-month | time of day fell asleep presented as hours corresponding the the time of day from midnight as 0 hours (e.g., 22.5 hours means they fell asleep at 10:30 pm) |
| Secondary | Sleep Offset Time | 1-month | time of day waking from nighttime sleep presented in hours from midnight as time 0 (e.g., 7.5 hours means they woke up at 7:30 am) |
| Secondary | Adverse Events Time 0 | hospital discharge assessed up to 7 days | Evaluation of adverse events asking participants to report any side effects of study interventions; Number of patients with any adverse event reported or noted on symptom screening checklist |
| Secondary | Adverse Events Time 1 | 1-month | Evaluation of adverse events asking participants to report any side effects of study interventions |
| Other | Reason for Non-adherence | 1-month | qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan |
| Other | Health Related Quality of Life | 1-month | Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life. |
| Other | Cognitive Functioning | 1-month | Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. |
| Other | Physical Functioning | 1-month | Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup |
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
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GET https://conductscience.org/api/trials/v1/NCT04932096/registered