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Trial registered on ANZCTR


Registration number
ACTRN12621000733875
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
10/06/2021
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial investigating the impact of a herbal supplement on sleep in individuals with insomnia symptoms
Scientific title
Investigating the impact of a herbal supplement on sleep in adults with insomnia symptoms
Secondary ID [1] 303837 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 321365 0
Condition category
Condition code
Alternative and Complementary Medicine 319146 319146 0 0
Herbal remedies
Neurological 319632 319632 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320139 0
Treatment: Other
Comparator / control treatment
This is a randomised, triple-blind (participant, observer, outcome assessor), placebo-controlled trial.

Placebo contains: Water, Glycerol BP, Natural Passionfruit Flavour Potassium Sorbate, Sodium Benzoate, and Citric Acid
Control group
Placebo

Outcomes
Primary outcome [1] 327022 0
Change in Insomnia Severity Index score from baseline
Timepoint [1] 327022 0
Baseline (Day 0), Mid-study (Day 14), and 4 weeks after treatment commencement (Day 28, primary outcome)
Secondary outcome [1] 393484 0
average sleep onset latency assessed using actigraphy and sleep diaries (change from baseline)
Timepoint [1] 393484 0
Daily for 2 weeks before intervention commencement (run-in phase, day -14-0) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [2] 393486 0
wake time after sleep onset assessed using actigraphy (change from baseline)
Timepoint [2] 393486 0
Daily for 2 weeks before intervention commencement (run-in phase) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [3] 393487 0
average number of awakenings during the night assessed using actigraphy (change from baseline)
Timepoint [3] 393487 0
Daily for 2 weeks before intervention commencement (run-in phase, day -14-0) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [4] 393494 0
average sleep efficiency assessed using actigraphy and sleep diaries (change from baseline)
Timepoint [4] 393494 0
Daily for 2 weeks before intervention commencement (run-in phase) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [5] 393495 0
daily mood assessed using the Profile of Mood States - mean total score (change from baseline)
Timepoint [5] 393495 0
Daily for 2 weeks before intervention commencement (run-in phase) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [6] 393496 0
subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (change from baseline)
Timepoint [6] 393496 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [7] 393503 0
effort to sleep assessed using the Glasgow Sleep Effort Scale (change from baseline)
Timepoint [7] 393503 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [8] 393505 0
arousal before bedtime assessed using the Pre-Sleep Arousal Scale (change from baseline)
Timepoint [8] 393505 0
Daily for 2 weeks before intervention commencement (run-in phase) and daily for 2 weeks from mid-treatment to the end of the treatment period (Day 14-28)
Secondary outcome [9] 393506 0
symptoms of depression, anxiety and stress assessed using the Depression Anxiety Stress Scales (change from baseline)
Timepoint [9] 393506 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [10] 393507 0
daytime sleepiness assessed using the Epworth Sleepiness Scale (change from baseline)
Timepoint [10] 393507 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [11] 393508 0
Skin Lustre using the Skin Lustre Questionnaire (change from baseline)
Timepoint [11] 393508 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [12] 393509 0
quality of life assessed using the WHO Quality of Life Instrument (WHOQOL-BREF)
Timepoint [12] 393509 0
Baseline (Day 0) and 4 weeks after treatment commencement (Day 28)
Secondary outcome [13] 393512 0
adverse events assessed using the Leeds Sleep Evaluation Questionnaire
Timepoint [13] 393512 0
At follow-up (Day 28)

Eligibility
Key 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
Minimum age
22 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation sequence generated by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In order to observed an effect size of 0.5 and SD=0.5 on the ISI between groups at follow up, with a=0.05 and ß=80%, we need a sample of 17 per group. A total of 40 (n=20 per group) people will be recruited to account for 15% attrition.

Independent samples t-tests or Chi-square tests will be used to check baseline balance between the two groups, and change from baseline will be assessed within groups. A repeated-measures analysis of variance (ANOVA) will be used to examine the main effects of group (intervention and placebo) and time (baseline and post-study), and their interaction, on the ISI scores, and all secondary measures. The effect sizes will be calculated using partial eta square. For participants who have clinical insomnia (ISI=10) at baseline, a clinically significant ISI change score will be calculated, as defined as reduction of 8-points or more on the ISI, and remission rate will be calculated as the proportion of participants who fall below an ISI of 10 post-study in each group. Within group paired samples t-tests will be employed to determine if there are any statistically significant within-treatment effects in the outcome measures at each time point. An intention-to-treat analysis will be applied.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308232 0
Commercial sector/Industry
Name [1] 308232 0
Melrose Health
Country [1] 308232 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Melrose Health
Address
6/18 Lionel Rd, Mount Waverley VIC 3149
Country
Australia
Secondary sponsor category [1] 309151 0
None
Name [1] 309151 0
Address [1] 309151 0
Country [1] 309151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308214 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 308214 0
Wellington Rd, Clayton VIC 3800
Ethics committee country [1] 308214 0
Australia
Date submitted for ethics approval [1] 308214 0
22/03/2021
Approval date [1] 308214 0
20/04/2021
Ethics approval number [1] 308214 0
26800

Summary
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.
Trial website
beautysleeptrial.weebly.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109958 0
Dr Melinda Jackson
Address 109958 0
Turner Institute of Brain and Mental Health, Monash University
18 Innovation Walk, Clayton, VIC 3800
Country 109958 0
Australia
Phone 109958 0
+61 399050206
Fax 109958 0
Email 109958 0
[email protected]
Contact person for public queries
Name 109959 0
Flora Le
Address 109959 0
Turner Institute of Brain and Mental Health, Monash University
18 Innovation Walk, Clayton, VIC 3800
Country 109959 0
Australia
Phone 109959 0
+61411513351
Fax 109959 0
Email 109959 0
[email protected]
Contact person for scientific queries
Name 109960 0
Melinda Jackson
Address 109960 0
Turner Institute of Brain and Mental Health, Monash University
18 Innovation Walk, Clayton, VIC 3800
Country 109960 0
Australia
Phone 109960 0
+61 399050206
Fax 109960 0
Email 109960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.