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
10
Participants Needed
1
Research Sites
21 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 aged 55 and older who have insomnia. The trial aims to understand if inhaled melatonin affects sleep patterns, such as how quickly participants fall asleep, differently than oral tablets. This is an early phase 1, randomized open-label crossover study conducted to explore these potential differences in sleep quality and neuroinflammation markers. Participants will receive two treatments in different periods: inhaled melatonin delivered by a pressurized inhaler at a dose of 100 micrograms (two puffs) nightly for two weeks, and oral melatonin tablets at a dose of 4 mg (two tablets) nightly for two weeks. After each treatment period, there is a one-week washout before crossing over to the other treatment. The study includes overnight stays in a sleep laboratory for sleep monitoring and blood collection visits to assess biomarkers. During the study, participants will visit the research center five times: for screening, overnight sleep studies at the start of each treatment period, and blood collection after each treatment. They will complete daily sleep diaries to record their sleep quality during the two-week treatment periods. Researchers will measure sleep onset latency primarily and also assess sleep time, wakefulness after sleep onset, insomnia severity, and subjective sleep quality. Safety and adherence will be monitored throughout the study, which is expected to end in May 2026.
CONDITIONS
Brief Title
A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy 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 early waking for at least 3 nights per week for at least 3 months
- Insomnia Severity Index score of 15 or higher
- Subjective sleep onset latency of 30 minutes or more on at least 3 nights per week in the past 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 above 15)
- Circadian disorders, narcolepsy, severe restless legs syndrome, REM sleep behavior disorder, or uncontrolled psychiatric disorders
- History of attempted suicide or current suicidal thoughts
- Objective cognitive decline with Montreal Cognitive Assessment score 26 or below
- Regular shift work, jet lag, or recent trans-meridian travel over 2 hours time difference
- Pregnancy or lactation; women of childbearing potential 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, or drugs affecting CYP1A2 enzymes
- Regular use of THC or CBD products within 14 days prior to the trial
- Drug or alcohol dependence within the past 2 years (alcohol limited to 2 standard drinks per day)
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 weeks
Participants receive either inhaled melatonin or oral melatonin tablets each night for two weeks before habitual bedtime while completing a sleep diary to assess subjective sleep quality.
1 overnight visit at the start and 1 visit after treatment for blood sample collection
Duration - 1 week
Participants have a 1 week washout period between treatment periods without study drug.
No visits during this period
Duration - Two weeks
Participants receive the alternate melatonin formulation each night for two weeks before habitual bedtime while completing a sleep diary to assess subjective sleep quality.
1 overnight visit at the start and 1 visit after treatment for blood sample collection
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
M
Mathew N Leslie, 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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