PEPSLE Screening - RDC Clinical

PEPSLE | Screening Script

PEPSLE Screening and Participant Details

"*" indicates required fields

The aim of this study is to assess the safety and effective dose of a plant-based sleep aid, PeptiSleep in healthy males and females with mild to moderate sleep impairment.
PeptiSleep is a natural, plant-based supplement made from hydrolysed brown rice (Oryza sativa) protein. The supplement contains bioactive peptides which may relieve stress and promote healthier sleep. These peptides have been shown to reduce cortisol levels, and as such could positively influence the quality and quantity of sleep.

Participation in the study is approximately 10 weeks which includes a 14 day pre-study period during which we will monitor your regular sleep habits to determine your baseline data and check your eligibility for the study.

First we will ask you to attend a pre-study appointment at our clinic in Fortitude Valley where you will complete some general questionnaires and be provided with a sleep diary and an Oura ring which is a wearable Smart Ring which will monitor your sleep habits throughout the study

After 14 days of wearing the ring you will then return to the clinic for your baseline visit where we will check your Sleep Scores and confirm if you are suitable for the study.

If you are eligible to continue you will be randomised on a chance basis to 1 of 4 different study groups - there are 3 different doses of PeptiSleep and 1 placebo group in this study, so you will have a 75% chance of receiving the active product and a 25% chance of receiving placebo product.
You will then be given a study product that corresponds with your group and provided with dosage instructions along with completing your baseline requirements including general measurements, a fasted blood test and some questionnaires.

You will start taking your study product on the evening of Day 1 and continue each evening until your last dose on the evening of Day 56. During the on-study phase you will be required to wear the Oura ring 24/7 (except when charging) and fortnightly be required to complete Salivary Cortisol tests, Questionnaires, and a sleep diary.
We will be in touch regularly throughout the study to see how you are doing and you can reach out to us at any time if you need anything.
On Day 57 you will be required to return to the clinic to repeat all of your baseline measures including the a fasted blood test and questionnaires.

You will receive phone calls, emails, and/or SMS texts throughout your enrolment period reminding you of what you need to do and when you need to do it.
The Oura Ring is supplied at no cost to you for the duration of the study. If you complete the study and all study activities, the Oura ring you used in the study will be offered for you to keep. If you don’t complete the study, you will be required to return the Oura ring along with all the contents of the kit so that we can pass the ring to another participant.

Please note that if you wish to keep your Oura ring after completing the study, and have ongoing access to your data after the study you will need to subscribe to Ouras services.>/p>

You will be eligible for reimbursement of up to $200 for your time and travel expenses. The reimbursement will be made via direct deposit to your nominated bank account once your participation in the study concludes. The maximum reimbursement is $200 for full completion of all study assessments and partial completion of the study will be reimbursed on a pro rata schedule.

Do you have any questions relating to the study process?

Trial Coordinators Initials*

Participant still interested after study summary?*

Yes

Initials of participant that is not interested in continuing to screening...

Screening Questions

Gender

Female

Male

Are you aged 18-65?

Yes

Not Eligible

What is your current height?*

in metres

Please enter a number less than or equal to 3.

What is your current weight?*

in kgs

BMI*

Must be between 18.5 - 33

Not Eligible

Are you currently experiencing disturbed sleep?

(defined as difficulty falling asleep, waking up during the sleep cycle or waking up too early and being unable to fall back to sleep)

Yes

Not Eligible

Are your sleep issues caused by external factors such as children, a partner or noisy neighbours?

Yes

Not Eligible

Are you currently or have you in the last month used any treatments for sleep, stress depression or anxiety, including prescribed or over the counter medications, supplements or aromatherapy?

Excluded : any medications that induce CYP3A4 such as Phenobarbital, phenytoin, Rifampicin, St Johns Wort, Glucocorticoids, any prescription or OTC medications for sleep, stress, depression or anxiety, including CBD, aromatherapy for sleep/stress/depression or anxiety.

Yes

Not Eligible

Do you agree not to use any other medications, supplements or aromatherapy treatments for sleep, stress, anxiety or depression for the duration of the study?

(apart from the study product)

Yes

Not Eligible

The OURA ring sleep that we will ask you to use throughout the study requires a smart phone with a Bluetooth and data connection, do you have a device with these capabilities?

Yes

Not Eligible

Are you willing to wear the OURA ring for the duration of the study, removing it only to charge?

The OURA can take between 20 and 80 minutes to charge, and battery should last approximately 1 week.

Yes

Not Eligible

Do you agree not to use any other digital devices (apart from the provided OURA ring) to help monitor or manage your sleep during the study period?

Yes

Not Eligible

Do you work night-shift employment and unable to have a normal night's sleep?

Yes

Not Eligible

Do you regularly have stimulants (e.g., coffee, caffeine supplements, beverages containing caffeine) in the 5 hours before bedtime?

Yes

Not Eligible

Do you regularly consume more than 500mg of caffeine per day?

One cup of brewed coffee contains about 70–140 mg of caffeine, or about 95 mg on average.
One shot of espresso is generally contains about 63 mg of caffeine. A double shot of espresso therefore contains roughly 125 mg of caffeine.
In a cup of black tea, there is approximately 50mg of caffeine, or half of what coffee contains. Green tea has about 33mg of caffeine, or two-thirds the amount of a cup of black tea.

Yes

Not Eligible

Have you been diagnosed with a chronic sleep disorder like insomnia, restless leg syndrome or sleep apnoea?

Yes

Not Eligible

Do you have any diagnosed or consistent gastrointestinal issues that disrupt sleep?

Yes

Not Eligible

Do you have any history of renal function impairment?

Yes

Not Eligible

Do you have any history of Chronic obstructive pulmonary disease (COPD) or a chronic breathing disorder?

Yes

Not Eligible

Do you agree not to change your current diet and/or exercise frequency or intensity during the entire enrolment period?

Yes

Not Eligible

Do you agree not to start any medications or supplements for sleep during the trial period?

Yes

Not Eligible

Are you currently participating in any other trials or have you in the last month?

Yes

Not Eligible

Have you participated in any other sleep trials in the last 3 months?

Yes

Not Eligible

Do you currently suffer from any unstable or serious illnesses?

Serious illness examples - mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions)
Unstable illnesses - diabetes or thyroid gland dysfunction.

Yes

If yes, provide brief detail

Not Eligible

Are there any medications or supplements that you take or use regularly?

Exclusion criteria - Glucocorticoids, Blood thinners/Anticoagulation therapies (Warfarin, coumadin, heparin, dalteparin, enoxaparin, aspirin).
Medications which induce CYP3A4 such as phenobarbital, phenytoin, rifampicin.
Treatment for depression, anxiety or sleep conditions (including supplements like Magnesium, Saffron, St Johns Wort, Melatonin or Valerian)
*1 month washout for stress or sleep-related supplements

Yes

Please list any medications or supplements below

Name

Dose

Frequency

Reason

Prescribed? (Y/N)

Have you had or been treated for cancer in the past 2 years?

(Basal cell carcinoma ok)

Yes

Not Eligible

Do you have any serious mood or neurological conditions including MS, diagnosed depression, anxiety or bi-polar disorder?

Epilepsy/Schizophrenia etc excluded

Yes

Not Eligible

Do you smoke/use e-cigarettes or recreational drugs?

Yes

Not Eligible

Do you regularly drink more than 14 standard alcoholic drinks a week (or have you regularly in the past)?

Yes

Not Eligible

Any allergies to any drugs, supplements or foods?

Exclude any allergies to the active or placebo ingredients

Yes

List any allergies here and reactions here..

Are you currently attempting conception, pregnant or breastfeeding?

Yes

Not Eligible

Screening Result?

Passed

Failed

Need to check

Waitlisted

Screen Fail Reason / Notes :

Have you informed the participant that we have other studies recruiting that they may be eligible for?

Yes

Why not?

Did they seem interested in any other studies?

Yes

Unsure

Participant ID*

If person fails screening or is not interested, please just type xxxx. Do NOT put the actual participant ID in this field unless they have PASSED screening.

Are you happy to proceed with enrolment? I will start by asking a few baseline questions while we are on the phone.

Yes

Are you currently working?

Full Time

Part Time/Casual

Retired

Unemployed

Other

Do you have a partner?

Yes

Do you have children living at home with you?

Yes

Are you currently following any particular diet, such as vegetarian, keto etc. If yes, please provide details:

Do you exercise regularly?

Yes

Thank you for your time on the phone. We will now email you out a digital consent form for you to read and sign.
After this we'll send you out a screening questionnaire for you to complete, and if you score within the required range for this study we'll ask you to come in for a pre-study appointment and be fitted for your OURA ring.
Do you have any more questions?