Trial · NCT06801379
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study
NCT06801379, Early phase 1, Unknown, 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: Pharmacokinetic Study. Trials, record NCT06801379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06801379
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: Pharmacokinetic Study
- NCT number
- NCT06801379
- Status
- Unknown
- Phases
- Early phase 1
- Enrollment
- 5 participants, estimated
- Lead sponsor
- Woolcock Institute of Medical Research
- Conditions
- Insomnia
- Interventions
- Inhaled Melatonin (100 μg), Oral Melatonin (4 mg)
- First posted
- 2025-01-30
- Last updated
- 2025-07-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to maximum Melatonin concentration | 0-8 hours post-treatment. | Time to peak concentration (Tmax) of blood-based melatonin, analysed by melatonin ELISA. |
| Secondary | Melatonin area under the curve | 0-8 hours post-treatment. | Area under the curve (AUC) of blood-based melatonin analysed by melatonin ELISA. |
| Secondary | Maximum blood-based melatonin concentration | 0-8 hours post-treatment. | Maximum concentration (Cmax) of blood-based melatonin, analysed by melatonin ELISA. |
| Secondary | Melatonin half-life | 0-8 hours post-treatment. | Half-life (T½) of blood based melatonin, analysed by melatonin ELISA. |
| Secondary | Daytime sleepiness | Collected at t0 then every fifteen minutes during the first hour post-treatment, then once hourly until 8 hours post-treatment. | Participant subjective daytime sleepiness, determined by the Karolinska Sleepiness Scale, a 9-point Likert scale (ranging from "Extremely alert" = 1 to "Very sleepy, great effort to keep awake, fighting sleep" = 9). |
Source ClinicalTrials.gov
Outcomes0
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/NCT06801379
GET https://conductscience.org/api/trials/v1/NCT06801379/registered