The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine whether a night-time tea can improve subjective sleep quality in healthy sleepers and self-reported poor sleepers, compared to a control drink.

Detailed Description
-----------------
The study will adopt a randomised, double-blind, placebo controlled, crossover design. Sixty-eight healthy adults aged 18+ (34 good sleepers and 34 poor sleepers) will be recruited from the general population. Good sleepers will be recruited if they have a stable sleep-wake schedule (i.e. bed/wake time within the range of 22.00 - 09.00 and with at least 6.5 hours of sleep duration reported per night). Poor sleepers will be recruited if they report subjective sleep difficulties (i.e. poor sleep quality or unrefreshing sleep) and if they display a Pittsburgh Sleep Quality Index total score of >5. Participants will consume both an active tea, and a control tea in a counterbalanced order for 7 days (separated by a 7-day washout period). Participants will complete questionnaires assessing mood, quality of life and sleep and provide blood samples to assess immunological markers. Sleep monitoring will also be conducted using actigraphy sleep monitoring and sleep diaries. Assessments will be made at baseline and following 7 days supplementation.

Official Title
-----------------
The Effects of a Multi-ingredient Night-time Tea on Sleep Quality, Wellbeing and Markers of Immune Function: a Randomised, Controlled, Crossover Study

Conditions
-----------------
Mood, Poor Quality Sleep, Good Sleep Habit, Sleep

Intervention / Treatment
-----------------
* Dietary Supplement: Night Time Tea
* Dietary Supplement: Control Tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adults aged 18 years and above. Both good sleepers and poor sleepers will be recruited. Good sleepers will be recruited if they have a stable sleep-wake schedule (i.e. bed/wake time within the range of 22.00 - 09.00 and with at least 6.5 hours of sleep duration reported per night). Poor sleepers will be recruited if they report subjective sleep difficulties (i.e. poor sleep quality or unrefreshing sleep) and if they display a Pittsburgh Sleep Quality Index total score of >5. Exclusion Criteria: Both good and poor sleeper participants cannot participate if they display evidence of current or previous sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders); an initial screening for sleep disorders will be conducted using the Sleep Disorders Screening Checklist - 25 (SDS-CL). Participants must not be shift workers Cannot currently be participating in other research trials which will compromise the results here Participants cannot take part if they will be sleeping at a location other than their usual residence during participation Nor if they have experienced travel across multiple time zones within the last three months or will be experiencing travel across multiple time zones during the study Participants cannot take part if they have current or previous mood disturbances Are currently unwell with anything that impacts sleep Are currently using medication which affects the central nervous system Or are currently misusing alcohol or drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Tea - Good Sleepers<br> | Dietary Supplement: Night Time Tea<br>* Night-time Tea<br>|
| Active Comparator: Control Tea - Good Sleepers<br> | Dietary Supplement: Control Tea<br>* Feel New Tea<br>|
| Experimental: Active Tea - Poor Sleepers<br> | Dietary Supplement: Night Time Tea<br>* Night-time Tea<br>|
| Active Comparator: Control Tea - Poor Sleepers<br> | Dietary Supplement: Control Tea<br>* Feel New Tea<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consensus sleep diary (CSD) - Subjective sleep quality |  | Following 7 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consensus sleep diary (CSD) - Subjective sleep continuity (Total sleep time) |  | Following 7 days of intervention | 
| Consensus sleep diary (CSD) - Subjective sleep continuity (Time in bed) |  | Following 7 days of intervention | 
| Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep efficiency %) |  | Following 7 days of intervention | 
| Consensus sleep diary (CSD) - Subjective sleep continuity (Sleep latency) |  | Following 7 days of intervention | 
| Consensus sleep diary (CSD) - Subjective sleep continuity (Number of awakenings and wake after sleep onset) |  | Following 7 days of intervention | 
| Karolinska Sleepiness Scale (KSS) |  | Following 7 days of intervention | 
| Positive and negative affect schedule (PANAS) |  | Following 7 days of intervention | 
| World Health Organization Quality of Life- Brief (WHOQOL-BREF) |  | Following 7 days of intervention | 
| Short-Form Health Survey 36 (SF-36) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (Time in bed) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (Total sleep time) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (Sleep efficiency %) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (Number of awakenings) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (Sleep latency) |  | Following 7 days of intervention | 
| Actigraphy objective sleep measures (wake after sleep onset) |  | Following 7 days of intervention | 
| Immunological markers (Interleukins-6) |  | Following 7 days of intervention | 
| Immunological markers (Interleukins-10) |  | Following 7 days of intervention | 
| Immunological markers (Tumour Necrosis Factor - alpha (TNF-a)) |  | Following 7 days of intervention | 
| Immunological markers (C-Reactive protein) |  | Following 7 days of intervention | 
| Immunological markers (Cortisol) |  | Following 7 days of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Mood, Physical health, Mental health, Immunological function