Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07369869
Eligibility Criteria:
INCLUSION CRITERIA
* Participants must self-assess themselves as being in good health.
* Aged 25 to 60 years at the time of randomisation
* Fluent in English
* Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI).
EXCLUSION CRITERIA
* Member of own household currently participating in this trial
* Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
* History of seizures or epilepsy
* Shift working or have a history of shift work within the previous six months
* Currently, or within the previous 8 weeks, consuming any nutritional supplements.
* Participation in any other intervention research trials
* Sleeping at a location other than their usual residence more than two nights per week during participation
* Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
* Current or recent mood disturbances or Axis I disorders (descriptions will be given)
* Current misuse of alcohol and/or drugs
* Current smoker
* Recent (within the last 12 weeks) infection and/or use of antibiotic medication
* Pregnant, seeking to become pregnant or lactating
* Those using (including within the last 2 weeks) proton-pump inhibitors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT07369869
Study Brief:
Protocol Section:
NCT07369869