Centre for Chronic Diseases of Ageing

AIMS OF THE STUDY:

• Develop a fast-acting inhaled formulation of melatonin to treat sleep-onset insomnia that circumvents the drawbacks of oral melatonin, such as inconsistent absorption due to food intake, concurrent medications, age, race, or gender
• Examine the efficacy and pharmacokinetics of a novel inhaled formulation of melatonin through actigraphy, a sleep diary and melatonin ELISA

TRIAL OUTCOMES

• Primary Outcome: (PK Arm) Blood-based melatonin (PK Arm). Melatonin will be assessed using samples collected every 15 minutes throughout the first hour after treatment then hourly for the following 7 hours.
• Secondary Outcome: (Efficacy Arm) Sleep onset latency of insomnia patients, as assessed by polysomnography (PSG).
• Exploratory Outcomes:
• (Efficacy Arm) Neurophysiology profiles of insomnia patients, as assessed by PSG.
• (Efficacy Arm) Assess the effectiveness of inhaled melatonin on patient perception of sleep quality, determined by the Karolinska sleep diary.
• (Efficacy Arm) Blood based markers of dementia e.g. pTAU181:TAU 181, β-Amyloid 40:42.
• (PK Arm) Assess participant daytime drowsiness using the Karolinska Sleepiness Scale.

Recruitment will start early 2025

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