Actively Recruiting
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia Disorder: a Randomised Open-Label Crossover Trial
Led by Woolcock Institute of Medical Research · Updated on 2025-07-18
5
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new inhaled form of melatonin compared to oral melatonin tablets in adults with insomnia. The study aims to understand if inhaled melatonin reaches peak blood concentration and is cleared from the body differently than oral tablets. This early phase 1 randomised open-label crossover trial focuses on adults aged 55 and older with insomnia disorder, exploring how the delivery method affects melatonin's absorption and elimination. Participants will receive two treatments in random order: inhaled melatonin (100 bcg via pressurized metered dose inhaler) and oral melatonin tablets (4 mg). Each treatment is taken once during a daytime visit, followed by blood sampling over an 8-hour period to measure melatonin levels at multiple time points. There is a one-week washout period between treatments. The study involves three visits total, including screening and two treatment visits. During each treatment visit, participants stay in the lab for about 8 hours, providing blood samples every 15 minutes during the first hour and then hourly. They will also rate their sleepiness using the Karolinska Sleepiness Scale at each blood collection. Researchers will measure the time to maximum melatonin concentration, melatonin area under the curve, peak blood concentration, melatonin half-life, and daytime sleepiness. This comprehensive monitoring helps compare the effects of inhaled versus oral melatonin on sleepiness and blood melatonin levels.
CONDITIONS
Brief Title
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of insomnia disorder as defined by the DSM-5 with difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week for at least 3 months
- Score of 15 or higher on the Insomnia Severity Index
- History of subjective sleep onset latency of 30 minutes or more on at least 3 nights per week in the previous 4 weeks
- Able to provide informed electronic consent
- Fluent in English
- Adults aged 55 years or older
You will not qualify if you...
- Highly dependent on medical care as determined by a medical officer
- Untreated moderate to severe sleep apnea (oxygen desaturation index over 15) without effective treatment
- Circadian disorders, narcolepsy, severe restless legs syndrome, REM sleep behaviour disorder, or uncontrolled psychiatric disorders
- History of attempted suicide or current suicidal thoughts
- Cognitive decline as measured by Montreal Cognitive Assessment score less than 26
- Regular shift work, jet lag, or trans-meridian travel over 2 hours in the past week
- Pregnancy or lactation; females with fertile partners must have a negative pregnancy test and use contraception
- Any condition contraindicating participation due to safety or compliance concerns
- Participation in another investigational study within 4 weeks
- Ongoing use of certain medications including antipsychotics, stimulants, hypnotics, opioids, THC or CBD products, CYP1A2 inhibitors or inducers
- Dependence on drugs or alcohol within the past 2 years (alcohol limited to 2 standard drinks per day during trial)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two 2-week treatment periods separated by a 1-week washout
Participants receive either inhaled melatonin or oral melatonin tablets in a randomized order, with each treatment lasting two weeks before bedtime. During treatment, participants attend a daytime laboratory visit to take the assigned melatonin dose once in the morning and remain for approximately 8 hours for blood sampling and sleepiness assessments.
2 daytime laboratory visits (one per treatment) with frequent blood sampling over 8 hours each visit
Trial Site Locations
Total: 1 location
1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
Research Team
H
Hui Xin Ong, PhD
D
Darren Zhao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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