NCT05478980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

October 27, 2021

Last Update Submit

October 11, 2022

Conditions

MoodPoor Quality SleepGood Sleep HabitSleep

Keywords

SleepMoodPhysical healthMental healthImmunological function

Outcome Measures

Primary Outcomes (1)

  • Consensus sleep diary (CSD) - Subjective sleep quality

    Following 7 days of intervention

Secondary Outcomes (20)

  • 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

  • +15 more secondary outcomes

Study Arms (4)

Active Tea - Good Sleepers

EXPERIMENTAL
Dietary Supplement: Night Time Tea

Control Tea - Good Sleepers

ACTIVE COMPARATOR
Dietary Supplement: Control Tea

Active Tea - Poor Sleepers

EXPERIMENTAL
Dietary Supplement: Night Time Tea

Control Tea - Poor Sleepers

ACTIVE COMPARATOR
Dietary Supplement: Control Tea

Interventions

Night Time TeaDIETARY_SUPPLEMENT

Night-time Tea

Active Tea - Good SleepersActive Tea - Poor Sleepers
Control TeaDIETARY_SUPPLEMENT

Feel New Tea

Control Tea - Good SleepersControl Tea - Poor Sleepers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Performance Nutrition Research Centre

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Sleep HygienePsychological Well-Being

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Fiona Dodd

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

July 28, 2022

Study Start

November 3, 2021

Primary Completion

August 17, 2022

Study Completion

August 17, 2022

Last Updated

October 12, 2022

Record last verified: 2021-10

Locations

GB(1)