Trial · NCT06802913
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep onset latency | Day 1 | Sleep onset latency (minutes) as assessed by polysomnography (PSG) on the first night of therapy. Sleep onset latency is the time between lights out and the first 30 second epoch scored as sleep using the American academy of sleep medicine criteria. |
| Secondary | Insomnia Severity Index | Measured during the initial screening visit and day 14 of treatment. | The Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 28) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity. |
| Secondary | Wake after sleep onset | Day 1 | Wake after sleep onset (WASO) is measured in minutes and is calculated from the first epoch of any sleep detected on the polysomnogram until the last epoch of sleep detected on the polysomnogram. |
| Secondary | Total sleep time | Day 1 | Total sleep time (TST) is measured in minutes and is the sum of all 30 second epochs scored as sleep during an overnight polysomnogram. |
| Secondary | Participant perception of sleep quality | Every observation for two weeks | Ordinal rating of sleep quality (How would you rate the quality of your sleep? 9 = best ever sleep, 5 = neither best nor worst sleep, 1 = worst sleep ever), assessed in the Karolinska sleep diary after waking every day for two weeks. |
| Other | Traditional sleep staging | Day 1 | Proportion of the sleep opportunity scored at the 5 stages (wake, and N1, N2, N3, and REM sleep) between lights out and lights on, measured using overnight in-laboratory polysomnography, scored by a polysomnography technician in accordance with AASM Sleep Scoring criteria. |
| Other | Absolute Electroencephalography (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep | Day 1 | Spectral power of low delta (0.5-1 Hz), delta (1-4.5 Hz), theta (4.5-8 Hz), alpha (8-12 Hz), sigma (12-15 Hz), beta (15-25 Hz), and gamma (25-40 Hz) frequency ranges between treatment arms. Power spectral analysis will be applied to EEG signals from polysomnography during NREM sleep after artefacts are detected and removed. |
| Other | Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep | Day 1 | Spectral power of low delta (0.5-1 Hz), delta (1-4.5 Hz), theta (4.5-8 Hz), alpha (8-12 Hz), sigma (12-15 Hz), beta (15-25 Hz), and gamma (25-40 Hz) frequency ranges between treatment arms. Power spectral analysis will be applied to EEG signals from polysomnography during REM sleep after artefacts are detected and removed. |
| Other | Blood levels of glial fibrillary acidic protein | Day 14 of treatment. | Blood-based glial fibrillary acidic protein (GFAP) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of interleukin-6 | Day 14 of treatment. | Blood-based interleukin-6 (IL-6), as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of plasma tau | Day 14 of treatment. | Blood-based plasma tau within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of granulocyte-macrophage colony-stimulating factor | Day 14 of treatment. | Blood-based granulocyte-macrophage colony-stimulating factor (GM-CSF) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of brain derived neurotrophic factor | Day 14 of treatment. | Blood-based brain derived neurotrophic factor (BDNF) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of neurofilament light chain | Day 14 of treatment. | Blood-based neurofilament light chain (NFL) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of amyloid β (Aβ) | Day 14 of treatment. | Blood-based Aβ (Aβ40:Aβ42 ratio) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
| Other | Blood levels of C-reactive protein | Day 14 of treatment. | Blood-based C-reactive protein (CRP) within each participant, as measured by SIMOA blood neuro-metabolite assay. |
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/NCT06802913/registered