Trial · NCT01906866
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Sleep Time (TST) | 13 weeks | The treatment effect of Circadin® 2/5 mg minitabs was compared to that of a placebo on total sleep time, as assessed by the Sleep and Nap Diary questionnaire, following 13 weeks of double-blind treatment |
| Secondary | Sleep Latency (Mins) | 13 weeks | Sleep Latency (minutes) derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo. The lower the value for sleep latency, the better the outcome. |
| Secondary | Duration of Wake After Sleep | 13 weeks | Duration of Wake after Sleep onset period derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo. The shorter the value, the better the outcome. |
| Secondary | Number of Awakenings Per Night | 13 weeks | Number of awakenings per night will be assessed by a Sleep and Nap Diary and summarized after 13 weeks of double-blind treatment for each treatment group using descriptive statistics. The smaller the number, the better the outcome. |
| Secondary | Longest Sleep Period | 13 weeks | The longest sleep period following 13 weeks of double-blind treatment with Circadin 2/5 mg and placebo was evaluated by a Sleep and Nap Diary questionnaire. The longer the sleep period, the better the outcome. |
| Secondary | Social Functioning - Children Global Assessment Scale (CGAS) | 13 weeks | The Children's Global Assessment Scale (CGAS) Questionnaire measures social functioning at home, in school, and in community settings. The scores range from 1, which is the very worst, to 100, which is the very best. |
| Secondary | Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ) | 13 weeks | The Strengths and Difficulties Questionnaire (SDQ) is a brief, 25-item, measure of behavioral and emotional difficulties that can be used to assess behavior at home and in school in children. The SDQ consists of 25 items which are divided into 5 subscales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); and 5) prosocial behavior (5 items). Subscales 1 to 4 are summed to generate a Total Difficulties Score (that ranges from 0 to 40). Each item on the SDQ is scored on a 3-point ordinal scale with 0 = not true, 1 = somewhat true, and 2 = certainly true, with higher scores indicating larger problems. |
| Secondary | Number of Dropouts | 13 weeks | Number of dropouts during the 13 weeks of double-blind treatment in the Circadin 2/5 mg and placebo arms. |
| Secondary | Assessment of Sleep Parameters by Actigraphy | 13 weeks | Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity over days to weeks using a noninvasive device. Despite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device and/or took it off sometime during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night. |
| Secondary | Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary. | 13 weeks, 26 weeks, 52 weeks. | Treatment Emergent Signs and Symptoms (TESS). Signs and symptoms not seen at baseline (i.e. before starting the treatment) and/or worsened even if present at baseline. |
| Secondary | Safety and Tolerability - Blood Pressure (mmHg) | 13 weeks, 26 weeks, 52 weeks. | Systolic and Diastolic Blood Pressure (mmHg) A normal blood pressure (BP) level is lower than 140/70 mmHg, meaning systolic BP values lower than 140 mmHg, and diastolic BP values lower than 70 mmHg. Values within the normal range mean good safety and tolerability outcomes. |
| Secondary | Safety and Tolerability - Pulse (Beats Per Minute) | 13 weeks, 26 weeks, 52 weeks. | Safety and tolerability of Circadin treatment compared to placebo: Pulse rate. The normal pulse for healthy adults ranges from 60 to 100 beats per minute (bpm). Values within the normal range mean good safety and tolerability outcomes. |
| Secondary | Safety and Tolerability - Respiratory Rate (Bpm) | 13 weeks, 26 weeks, 52 weeks. | Respiratory rate (breaths per minute). The normal respiratory rate for elderly individuals living independently is 12-18 breaths per minute while it is 16-25 breaths per minute for those needing long-term care. Values within the normal range mean good safety and tolerability outcomes. |
| Secondary | Safety and Tolerability - Body Temperature (°C) | 13 weeks, 26 weeks, 52 weeks. | Body Temperature (°C). Normal body temperature varies by person, age, activity, and time of day. It ranges from 36.1°C to 37.2°C. Values within the normal range mean good safety and tolerability outcomes. |
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/NCT01906866/registered