Trial · NCT06476392
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in change in average pain intensity during the last 7 days between groups | Difference in change from baseline to 6 weeks | Average pain intensity during last 7 days will be assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain') |
| Secondary | Insomnia severity | Baseline and after 6 weeks | Insomnia will be assessed with the Insomnia Severity Index (ISI), which is a brief 7 item patient-reported instrument with a score ranging from 0-28 (0=best;28=worst) |
| Secondary | Weekly pain intensity score trajectory | Weekly from baseline to 6 weeks | The trajectory of weekly numerical rating scale (NRS) pain intensity scores assessed on a 0-10 Numeric Rating Scale (NRS) (ranging from 'no pain to 'worst imaginable pain') from baseline to 6 weeks |
| Secondary | 30% pain intensity responders | Change from baseline to 6 weeks | Difference in number of patients with more than 30% improvement in pain intensity from baseline to 6 weeks |
| Secondary | 50% pain intensity responders | Change from baseline to 6 weeks | Difference in number of patients with more than 50% improvement in pain intensity from baseline to 6 weeks |
| Secondary | Global Perceived Effect (GPE) for pain | After 6 weeks | Assessment of overall change in pain from baseline to 6 weeks. Participants will be asked at 6 weeks: 'How is your pain now compared to when you entered this study', with 5 response options (much worse, worse, almost the same/unchanged, improved, much improved) |
| Secondary | Physical and Mental Health | Baseline and after 6 weeks | Physical and Mental Health will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health questionnaire version 1.2. Difference in change in physical and mental health scores between treatment groups from baseline to 6 weeks. PROMIS-10 consist of 10 questions concerning different aspects of global health. The first 9 questions are score on a Likert scale with 5 response options, and the last question asks about pain using a 0-10 numeric rating scale |
| Secondary | Back pain related disability | Baseline and after 6 weeks | Back pain related disability will be assessed using the Roland Morris Disability Questionnaire (RMQ). RMQ is a 23-item questionnaire (RMQ) developed to assess functional limitation and disability among patients with low back pain. The RMQ 23-item version will be used because 1) it has been cross-culturally validated in Danish (the original RMQ 24-item version has not), 2) the psychometric properties of the 23 vs 24 item RMQ have been shown to be similar. Each of the 23 items is yes/no (scored as 1 and 0 points respectively) with the scale ranging from 0 (no disability) to 23 (extremely severe disability). |
| Other | Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). SE is the ratio of TST to time in bed / 100% |
| Other | Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | REM sleep latency from Ear EEG in subgroup of 60 patients | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Time from sleep onset until first epoch of REM stage sleep from Ear EEG | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Number of awakenings within TST from Ear EEG | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Arousal index which is number of arousals per hour from Ear EEG | Baseline and week 4. | Difference in change in sleep metric between treatment groups (Melatonin \[n=30\] vs.placebo \[n=30\]) from baseline to 4 weeks. Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). |
| Other | Ease-of-use and Comfort with ear EEG | Baseline and week 4. | Three 0-10 questions are used: 1) How did you experience falling asleep with the ear EEG device, 2) How did you experience sleeping with the ear EEG device?, 3) How would you rate your experience of soreness or discomfort in your ears after sleeping with the device? A lower sum score is worse. |
| Other | Ear EEG adverse device effects | Baseline and week 4. | Any adverse device effect defined as an adverse effect related to the use of the ear EEG |
| Other | Age | Baseline | The age of the participant will be calculated using the date of randomisation and the date of birth. |
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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