None listed
Conditions
Brief summary
Insomnia is the most prevalent sleep disorder, affecting around 10% of Australians. The symptoms include difficulties getting to sleep, difficulties staying asleep, or early-morning awakenings with an inability to return to sleep. Insomnia may also be associated with problems with memory and attention, and increased feelings of depression, anxiety and stress. Insomnia can be treated effectively without medication, such as cognitive behavioural therapy for insomnia with a psychologist. However, there remain a large proportion of individuals who do not seek help possibly due to barriers such as geographical location or time constraints, or they do not wish to use pharmacological treatments for sleep. Further evidence for alternative therapies for insomnia, particularly those with milder forms of the disorder, are needed. Potential significance of the research project: Insomnia is a highly prevalent but neglected sleep disorder, with serious health consequences for patients and large financial costs to the health system. The use of a supplement for sleep in those with milder forms of the disorder could potentially provide a low cost, widely accessible, and effective treatment solution for people with insomnia across Australia, who would otherwise rely on sleep medication for better sleep. The aim of this project is to conduct a clinical trial to examine the effectiveness of a supplement compared to placebo for improving sleep outcomes in individuals with subclinical insomnia over a four week period. It is hypothesised that the supplement will reduce the severity of insomnia symptoms, and improve subjective and objective sleep quality, quantity, and associated daytime symptoms, compared to placebo.
Interventions
Melrose Health has formulated a product (Beauty Sleep) for sleep and skin health, which includes extracts of valerian, hops, passionflower, lemon balm, cherry juice, hyaluronic acid and melatonin, taken at night.
The dose is 10ml of liquid taken orally, once daily 30 minutes before bedtime for 4 weeks.
Bottle with any remaining liquid will be returned at the end of the trial.
Sponsors
Melrose Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
22 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Age between 22-60 years. Score between 8 and 14 on the Insomnia Severity Index to define sub-clinical to mild insomnia severity. Meet DSM-V definition of insomnia
Exclusion criteria
Subjects diagnosed with another sleep disorder (determined by self-report, may include OSA, restless legs syndrome, narcolepsy, etc). Subjects who are using sedatives or hypnotics or anti-depressants and are unwilling or unable to discontinue use during the study. Subjects using hormone therapy or other treatments that may interact with the study treatment. Subjects with major depression or other psychopathology (such as anxiety, bipolar disorder, PTSD, schizophrenia). Subjects who are participating in cognitive behavioural therapy for insomnia (CBT-I) within 4 weeks of Session 1 or who will enter CBT-I during the study period. Subjects with serious illness (e.g. cardiovascular disease, diabetes) that make them unsuitable for the study. Subjects who are allergic to any of the treatment ingredients. Pregnancy, breast-feeding or women intending to become pregnant during the course of the study. Currently taking other over-the-counter medicine for sleep or melatonin in the past month.
Outcome results
None listed