Clinical trials

This pilot randomised, open-label, parallel-group controlled trial will evaluate the feasibility, acceptability and effects of a psychologist-supported digital behavioural therapy for insomnia (dBTi) compared to a wait-listed active control (digital sleep health education) in young people aged 16-24 years with insomnia symptoms. The primary objectives are to evaluate the feasibility of conducting a full-scale trial by assessing recruitment, consent and randomisation rates, intervention uptake, and data completeness. Secondary objectives include exploring treatment effects on insomnia severity (Insomnia Severity Index), sleep diary metrics, sleep quality, fatigue, and mood (depression and anxiety symptoms). Post-intervention interviews will assess participant experience and acceptability. Results will inform the design of a larger randomised controlled trial.

This research project aims to better understand the neurobiological mechanistic underpinnings of insomnia disorder. The main question is whether cortical hyperarousal in individuals with insomnia disorder, measured by electroencephalograhic (EEG) infraslow oscillation coupling of sigma power during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep, is related to locus coeruleus activity.

This project aims to elucidate whether CBCTi changes symptom severity or even remission of anxiety disorders as compared with a delayed-start control group. The investigators will use a delayed-start randomized controlled trial in a cohort of individuals with anxiety and insomnia (N=98) to compare the effects of an online therapist-guided cognitive behavioural and circadian therapy for insomnia versus control on overnight emotion regulation and mental health outcomes. The project will involve at-home assessments and in-lab visits. At-home assessment involves recording sleep and circadian rhythm measures with wearables and daily diaries. Participants will be invited to perform two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.

The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are: * Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo * Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo. Participants will: * Take 10mg Lemborexant nightly for two weeks * Take a matching placebo nightly for two weeks * Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).

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 the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia? 5 participants will: * Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total) * Take 100 μg of inhaled melatonin (2 inhaler puffs) once * Take a 4 mg of oral melatonin (2 tablets) once

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

The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).

The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.

The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.