Status:
UNKNOWN
Exploration of Relationships Between Sleep, Gut Health and Cognition
Lead Sponsor:
University of East Anglia
Conditions:
Insomnia
Sleep Disturbance
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
Our study aims to build on emerging evidence showing relationships between gut health, sleep and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological i...
Detailed Description
One-third of the UK adult population presents with disordered sleep, and the prevalence further increases with ageing. Disordered sleep has also been identified as a risk factor for dementia, which is...
Eligibility Criteria
Inclusion
- Aged over 55 years
- Conversational English and capacity to consent
- Availability to take part in the study
- Subjective sleep complaints of impaired sleep quality or insufficient sleep
- Participants with no clinical diagnosis or signs of dementia (m-ACE-III score above 21)
- Potential for sleep complications such as insomnia before the study
- A body mass index between 20 and 35 for men, and 18.5 and 35 for women
- High Score on Pittsburgh Sleep Quality Index (PSQI; \> 5) OR The Insomnia Severity Index (ISI; \> 10)
Exclusion
- Acute infections or diseases
- Psychiatric disorders or chronic neurological conditions include a diagnosis of dementia, mild cognitive impairment (MCI)/ prodromal AD.
- Learning, sensory, or motor impairment/ disabilities that would pose an unfair disadvantage in the cognitive tests
- Chronic pain conditions
- Currently taking blood thinning medications
- Current diagnosis of malignant tumours/ cancers
- Worked as a shift worker or travelled across more than three time zones in the past two months
- Alcohol consumption above 14 units/week and/ use or dependency of illicit substances/alcohol
- Consume more than 5 cups of caffeinated beverages (e.g., coffee/tea/coke, etc) per day.
- Smokers (tobacco, e-cigarettes, or vapes)
- Taking antibiotics, or any dietary supplements that may interfere with study outcomes.
- Self-quarantined or presumed positive status for COVID-19 (see considerations for COVID-19 in safety and comfort section).
- Currently enrolled or enrolled previously (within the last 2 months) in a drug trial.
- Participants who show signs or symptoms of having dementia.
- Participants with high scores (\>10) on the Patient Heath Questionnaire-9 (PHQ-9) depression scale and/ or who indicate that they have suicidal thoughts
- A diagnosis of untreated sleep apnoea or another sleep-related disorder excluding insomnia
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05315986
Start Date
April 29 2022
End Date
December 15 2022
Last Update
April 7 2022
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