Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment

Change from baseline to the end of the study period in safety including electrolytes and liver function markers via blood test

Change from baseline to the end of the study period in Sleep Quality via Leeds Sleep Evaluation Questionnaire (LSEQ). The LSEQ comprises ten self-rating 100-mm-line analogue questions concerned with aspects of sleep and early morning behaviour. A visual analogue scale is used with two extreme states defined at the ends of the line (e. g. Tired = score of 0, Alert = score of 10). The subject responds by placing a vertical mark on the line to indicate his present self- evaluation.

The four subscales are as follows:

• The ease of getting to sleep (GTS), questions 1-3
• The perceived quality of sleep (QOS), questions 4-5
• The easy of awakening from sleep (AFS), questions 6-7
• The integrity of behaviour following wakefulness (BFW), questions, 8-10

Change from baseline to the end of the study period in Insomnia Severity via Insomnia Severity Index (ISI). The questionnaire has seven questions. The seven answers are added up to get a total score.

Total score categories:

• 0-7 = No clinically significant insomnia
• 8-14 = Subthreshold insomnia
• 15-21 = Clinical insomnia (moderate severity)
• 22-28 = Clinical insomnia (severe)

Change from baseline to the end of the study period in Sleep Onset Time via Consensus Sleep Diary (CSD)

Change from baseline to the end of the study period in self reported Sleeping Pattern and number of Disturbance as recorded using a Consensus Sleep Diary (CSD)

Change from baseline to the end of the study period in Day Time Sleepiness and Nap Count via the Epworth Sleepiness Scale (ESS). The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher the propensity for daytime sleepiness

• Scores 0-5 Lower Normal Daytime Sleepiness
• Scores 6-10 Higher Normal Daytime Sleepiness
• Scores 11-12 Mild Excessive Daytime Sleepiness
• Scores 13-15 Moderate Excessive Daytime Sleepiness
• Scores 16-24 Severe Excessive Daytime Sleepiness.

Change from baseline to the end of the study period in Stress via a self reported questionnaire - Perceived Stress Scale (PSS). The questions in this scale ask about feelings and thoughts during the last month. The questionnaire asks the participant to indicate how often they felt or thought a certain way with 0 meaning never and 4 meaning very often.

PSS scores are calculated by:

• First, reverse your scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
• Add up your scores for each item to get a total.
• Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
• Scores ranging from 0-13 would be considered low stress.
• Scores ranging from 14-26 would be considered moderate stress.
• Scores ranging from 27-40 would be considered high perceived stress

Change from baseline to the end of the study period in Stress via a self reported questionnaire called Profile of Mood States (POMS). The questionnaire contains 65 words that describe feelings which are rated from 0-4. Scores are calculated:

• Tension = Tense, Shaky, On Edge, Panicky, Relaxed, Uneasy, Restless, Nervous and Anxious
• Depression = Unhappy, Sorry for Things Done, Sad, Blue, Hopeless, Unworthy, Discouraged, Lonely, Miserable, Gloomy, Desperate, Helpless, Worthless, Terrified and Guilty
• Anger = Anger, Peeved, Grouchy, Spiteful, Annoyed, Resentful, Bitter, Ready to Fight, Rebellious, Deceived, Furious and Bad Tempered
• Fatigue = Worn Out, Listless, Fatigued, Exhausted, Sluggish, Weary and Bushed
• Confusion= Confused, Unable to Concentrate, Muddled, Bewildered, Efficient, Forgetful, and Uncertain About Things
• Vigour =Lively, Active, Energetic, Cheerful, Alert, Full of Pep, Carefree and Vigorous

Change from baseline to the end of the study period in Anxiety via Beck Anxiety Inventory (BAI) questionnaire. The BAI consists of 21 self-reported items on a four-point scale - ''not at all'' (0) to ''severely'' (3) to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63

• Minimal anxiety levels (0-7)
• Mild anxiety (8-15)
• Moderate anxiety (16-25)
• Severe anxiety (26-63)

Change from baseline to the end of the study period in Stress via Salivary cortisol test

Change from baseline to the end of the study period in Alertness via Reaction Time Test

Change from baseline to the end of the study period in markers associated with circadian cycles - melatonin and serotonin via blood test

Change from baseline to the end of the study period in Inflammatory Markers such as CRP, TNF-α and IL-6 via blood test

Change from baseline to the end of the study sleep onset latency measured in minutes using a wearable sleep tracker

Change from baseline to the end of the study in total sleep time during phases of light, deep and REM sleep measured in minutes via a wearable sleep tracker

Change from baseline to the end of the study in blood pressure measured in mmHG

Change from baseline to the end of the study in heart rate measured in beats per minute using a blood pressure machine

Change from baseline to the end of the study in body temperature measured in Celsius using a wearable sleep tracker

Change from baseline to the end of the study in BMI. The BMI is calculated by dividing weight in kilograms by height in meters squared and is measured in kg/m2.