Inhaled versus oral melatonin for adults with insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label crossover early-phase study compares nightly inhaled melatonin (100 µg) with oral melatonin tablets (4 mg) in adults aged 55+ who meet DSM-5 criteria for insomnia. Ten participants will be randomized to one treatment for two weeks, then cross over to the other treatment for two weeks, with an overnight polysomnography at the start of each treatment period and blood collection at the end of each period. The main outcomes are changes in sleep microarchitecture and sleep onset latency measured by polysomnography, with exploratory biomarker analyses from blood samples. Recruitment and all overnight visits occur at a single center in Macquarie Park, New South Wales, and several common sleep and psychiatric disorders are excluded.

Why it matters

Who can join: the full rules

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).

Where it's running

• Woolcock Institute of Medical Research
  Macquarie Park, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Hui Xin Ong, PhD — Woolcock Institute of Medical Research
• Study coordinator: Hui Xin Ong, PhD
• Email: huixin.ong@mq.edu.au
• Phone: 0298053094

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SleepCogni for children with chronic insomnia

  A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• Remote ischemic conditioning for post-stroke insomnia

  A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu, Sichuan · NCT07874594

• Nurse-guided app-based brief behavioral therapy for insomnia in older adults

  Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.

  Recruiting Taipei Medical University · Taipei · NCT07842250

• Three rTMS approaches to lessen insomnia-related pain after exercise-induced muscle soreness

  This study tests whether three different rTMS approaches can reduce pain sensitivity and improve recovery in adults with insomnia after inducing muscle soreness from exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07827677

• Insomnia and Sleep Disruption's Effect on Pain Sensitivity and Muscle Soreness After Exercise

  This study tests whether poor sleep or insomnia affects how people feel pain and recover from exercise-induced muscle soreness in healthy adults.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07827664

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.