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Study identifier: NCT06802913 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Insomnia  ·  Sponsor: Woolcock Institute of Medical Research

PhaseEARLY_Phase 1
Planned participants10
Who can joinAll sexes, 55 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Hui Xin Ong, PhD  ·  0298053094  ·  huixin.ong@mq.edu.au

Mathew N Leslie, PhD  ·  0298053094  ·  mat.leslie@woolcock.org.au

Always discuss trial participation with your own doctor first.

Locations (1)

Woolcock Institute of Medical ResearchMacquarie Park, New South Wales, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT06802913