NCT06802913 A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study
| NCT ID | NCT06802913 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Woolcock Institute of Medical Research |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Diagnosis of insomnia disorder as defined by the DSM-5 (difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty) and a score ≥15 on the ISI. * History of subjective sleep onset latency (sSOL) ≥30 minutes on at least 3 nights per week in the previous 4 weeks. * Able to provide informed electronic consent. * Fluent English literacy. * Adults aged 55+ years old. Exclusion Criteria: * People highly dependent on medical care as determined by a medical officer. * Untreated moderate-severe sleep apnoea as diagnosed using in-home wrist oximetry (oxygen desaturation index\>15, ongoing effectively treated sleep apnoea with insomnia will be allowed). * Circadian disorders, narcolepsy, severe restless legs syndrome, and REM sleep behaviour disorder or uncontrolled psychiatric disorders. * History of attempted suicide or current suicide ideation (indicated by a score \>0 on Q9 of the Patient Health Questionnaire-9) at pre-screening. * Objective cognitive decline measured by scoring ≤26 on the Montreal Cognitive Assessment (MoCA) * Regular shift work, jet lag or trans-meridian travel (over 2h time difference) in the past week before randomisation. * Pregnancy or lactation. Female participants of childbearing potential with a fertile sexual partner must have a negative serum pregnancy test result at the screening visit. Women will be advised to use contraception for the duration of the study. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures. * Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment. * Ongoing use of anti-psychotic medication, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine or illicit stimulants. * Regular use of hypnotics (including melatonin, valerian, kava, benzodiazepines and Z-drugs), and other medications that can cause additive sedation (e.g. sedating antihistamines, tricyclic antidepressants, antipsychotics) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial. * Regular use of psychostimulants (e.g., dexamfetamine, lisdexamfetamine, methylphenidate) or non-amphetamine psychostimulants (e.g., armodafinil, modafinil, atomoxetine) within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial. * Use of antidepressant medications for treatment of low mood for less than one year or dose changes (escalation or tapering) or change in antidepressant medications within the past year. * Regular use opioids within 14 days or 4-5 half-lives (whichever is longer) of starting the clinical trial. * Ongoing use of THC- or CBD-containing products within 14 days prior to the start of the trial. * Dependence or any other drug or alcohol dependence within the past two years (alcohol to be limited to no more than 2 standard drinks per day during trial period). * Regular use of drugs that are CYP1A2 inhibitors (e.g. amiodarone, cimetidine, ciprofloxacin, fluvoxamine) or CYP1A2 inducers (e.g. carbamazepine, phenobarbital, rifampin, tobacco).
Contact & Investigator
Hui Xin Ong, PhD
PRINCIPAL INVESTIGATOR
Woolcock Institute of Medical Research
Frequently Asked Questions
Who can join the NCT06802913 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06802913 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06802913 currently recruiting?
Yes, NCT06802913 is actively recruiting participants. Contact the research team at huixin.ong@mq.edu.au for enrollment information.
Where is the NCT06802913 trial being conducted?
This trial is being conducted at Macquarie Park, Australia.
Who is sponsoring the NCT06802913 clinical trial?
NCT06802913 is sponsored by Woolcock Institute of Medical Research. The principal investigator is Hui Xin Ong, PhD at Woolcock Institute of Medical Research. The trial plans to enroll 10 participants.
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