Trial · NCT06802913
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
NCT06802913, Early phase 1, Recruiting, Woolcock Institute of Medical Research
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study. Trials, record NCT06802913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06802913
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
- NCT number
- NCT06802913
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Woolcock Institute of Medical Research
- Conditions
- Insomnia
- Interventions
- Inhaled Melatonin (100 μg), Oral Melatonin (4 mg)
- First posted
- 2025-01-31
- Last updated
- 2025-07-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06802913
GET https://conductscience.org/api/trials/v1/NCT06802913/registered