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The effects of melatonin, administered prior to sleep at an irregular time, on Rapid Eye Movement (REM) sleep and fear inhibition in healthy young adults

Placebo-controlled analysis of the effects of melatonin, administered prior to circadian misalignment, on REM sleep and fear inhibition in healthy adults aged 18-39 years

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001624279
Enrollment
40
Registered
2018-10-03
Start date
2019-05-27
Completion date
2022-06-03
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Circadian misalignment disrupts REM sleep, a stage of sleep which is important for fear memory processing. The aim of this study is to explore whether the sleep aid melatonin, when administered prior to circadian misalignment, will rescue REM sleep and recover fear inhibition processes. This study will provide important insight into the relationship between REM sleep and processes critical for treatment and recovery from Posttraumatic Stress Disorder (PTSD).

Interventions

Participants will undergo a 4-night/4-day experimental protocol. Night 1 is an adaptation night for habituation to sleeping within a laboratory environment. Participants will undergo normal, undisturbed sleep on Night 2. Circadian misalignment is induced by advancing the sleep episode by 4-hours on Night 3, and then a further 4-hours on Night 4. On Night 3 and 4, participants will be administered melatonin 3mg (experimental condition) or placebo (control condition) in capsule form prior to the a

Participants will undergo a 4-night/4-day experimental protocol. Night 1 is an adaptation night for habituation to sleeping within a laboratory environment. Participants will undergo normal, undisturbed sleep on Night 2. Circadian misalignment is induced by advancing the sleep episode by 4-hours on Night 3, and then a further 4-hours on Night 4. On Night 3 and 4, participants will be administered melatonin 3mg (experimental condition) or placebo (control condition) in capsule form prior to the advanced bedtime and according to the individual’s circadian phase. Medication and placebo containers will be returned to the study team as a check for adherence.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria are: 1) age 18–39 years-old; 2) regular sleep-wake schedule; 3) no current and unmanaged medical or psychiatric diagnoses; and d) no personal history of any Axis I diagnosis or family history of mood or psychotic disorders. Also, female participants will be studied in phases of the menstrual cycle in which estrogen levels are normal - high.

Exclusion criteria

Exclusion criteria are: 1) any sleep disorder revealed on the adaptation night (e.g., sleep apnea); and 2) not exhibiting consistent startle responding on the screening day (i.e., over 75% discernible responses to 6 108-dB 40-ms startle pulses).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026