Clinical Trial

A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study

Study acronym: Mela-Nia
Recruiting Early Phase 1
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Record status
This record was last updated July 18, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer is: does inhaled melatonin affect the sleep profiles of adults with insomnia differently than oral melatonin tablets? 10 Participants will: * Visit the research institute for a screening visit, for an overnight visit at the beginning of each study drug treatment and for a blood collection visit at the end of the conclusion of each study drug treatment period (5 visits in total) * Take 100 µg of inhaled melatonin (2 inhaler puffs) nightly for two weeks * Take a 4 mg of oral melatonin (2 tablets) nightly for two weeks
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-24; most recent amendment 2025-07-15.
Status change: Not Yet Recruiting → Recruiting 2025-07-15
Trial Details
NCT Number NCT06802913
Lead Sponsor Woolcock Institute of Medical Research
Conditions Insomnia
Enrollment 10 participants
Start Date 2025-07-01
Primary Completion 2025-12 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-07-18