Exploration of Relationships Between Sleep, Gut Health and Cognition

NCT05315986 | Unknown

• 1 other identifier: R210281
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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 interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia complaints. Our study also aims to test the feasibility of using wearable and commercially available EEG headband technology to measure objective sleep quality in the home, which will allow for a reliable and ecologically more valid sleep research.

Conditions

Insomnia; Sleep Disturbance

Keywords

sleep; polysomonography; food supplement; gut health; microbiome; cognition; EEG; Dreem3

Outcome Measures

Primary Outcomes (8)

• Number of nights on which participants used the Dreem headband over a 14 day period

  Frequency of Dreem headband usage over a 14 day period will be used to measure device adherence rates. Higher adherence rates will indicate higher levels of acceptability of the device as a method of measuring electrical activity (electroencephalogram) within the home environment

  2 weeks

• Mean percentage of Dreem device signal quality over a 14 day period

  Signal quality will range from 0-100%, with percentages \>80% indicating good signal quality. Higher signal quality will indicate higher levels of feasibility of the device as a method of measuring objective sleep quality based on electrical activity of the brain (electroencephalogram) within the home environment.

  2 weeks

• Number of Participants who report that they made changes to their sleeping habits following engagement in Enhanced Sleep Education (ESE).

  Frequency of participants who make self-reported changed to their sleeping habits will be used to measure adherence rates to the Enhanced Sleep Education (ESE) intervention. Higher adherence to the intervention will indicate higher acceptability of this method for treating sleep complaints.

  4 weeks

• Changes in scores on the self-reported sleep quality measure using the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo.

  Changes in scores on the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the PSQI would indicate improved sleep and suggest feasibility of using the described treatment conditions to improve subjective sleep complaints. (Highest score = 21, Lowest score = 0)

  4 weeks

• Changes in scores on the Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo.

  Changes in Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the ISI would indicate improved sleep and suggest feasibility of using the proposed treatment conditions to improve subjective sleep complaints. (Highest score = 28, Lowest score= 0)

  4 weeks

• Changes in objective sleep quality as measured by the sleep efficiency index based on the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.

  Sleep efficiency index will be measured using percentage (sleep efficiency = total sleep time / time in bed x 100). Changes in sleep efficiency index of sleep will be used to measure the feasibility of the proposed treatment conditions on improving objective sleep quality. Higher percentages of sleep efficiency suggest improved sleep.

  4 weeks

• Changes in the time spent awake following initial sleep onset (in minutes) as measured by the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.

  Changes in the time spent awake following initial sleep onset (in minutes) will be used to measure objective sleep quality. Decreases in time spent awake following initial sleep onset (in minutes) will suggest feasibility of proposed treatment conditions for improving objective sleep quality.

  4 weeks

• Mean number of days on which participants ingested the dietary supplements (Saffr'Inside) per subject over a 4 week period

  Frequency (mean number of days per subject) of ingestion of the dietary supplement will be used to measure the adherence rate of the supplement. Higher adherence rates will indicate higher levels of acceptability of using a supplement to improve sleep complaints.

  4 weeks

Secondary Outcomes (2)

• Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo.

  4 weeks

• Changes in the time to complete (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo.

  4 weeks

Other Outcomes (1)

• Changes in gut microbiome composition following a period of ingesting a dietary supplement (Saffr'Inside)

  4 weeks

Study Arms (4)

Group 1: Sleep intervention (ESE) & Saffron (food supplement)

EXPERIMENTAL

Saffron: Dietary supplement consists of a gummy sweet (Saffr'Inside; 30mg). Ingest one gummy per day for a duration of 4 weeks total. Enhanced Sleep Education (ESE): Receive a psycho-education based multi-component sleep intervention consisting of: Sleep education, Sleep hygiene, mindfulness and sleep behavioural recommendations adapted from the validated Brief Behaviour Treatment for Insomnia (BBTi) intervention.The intervention is presented to participants via a pre-recorded presentation, lasting approximately 15 minutes. Participants will also receive some personalized feedback from their objective sleep measurements, collected from their EEG data to help them better understand their sleep patterns.

Dietary Supplement: Saffr'Inside; 30mg; Behavioral: Enhanced Sleep Education

Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement)

EXPERIMENTAL

Placebo (no Saffron): Placebo food supplement identical looking (gummy sweet) to experimental food supplement. Ingestion of one gummy per day for a duration of 4 weeks total. Enhanced Sleep Education (ESE): Receive a psycho-education based multi-component sleep intervention consisting of: Sleep education, Sleep hygiene, mindfulness and sleep behavioural recommendations adapted from the validated Brief Behaviour Treatment for Insomnia (BBTi) intervention.The intervention is presented to participants via a pre-recorded presentation, lasting approximately 15 minutes. Participants will also receive some personalized feedback from their objective sleep measurements, collected from their EEG data to help them better understand their sleep patterns.

Behavioral: Enhanced Sleep Education; Dietary Supplement: Placebo food supplement

Group 3: No sleep intervention (Control ESE) & Saffron (food supplement)

EXPERIMENTAL

Saffron: Dietary supplement consists of a gummy sweet (Saffr'Inside; 30mg). Ingest one gummy per day for a duration of 4 weeks total. No Psycho-education (ESE) intervention. Control.

Dietary Supplement: Saffr'Inside; 30mg

Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement)

PLACEBO COMPARATOR

Placebo (no Saffron): Placebo food supplement identical looking (gummy sweet) to experimental food supplement. Ingestion of one gummy per day for a duration of 4 weeks total. No Psycho-education (ESE) intervention. Control.

Dietary Supplement: Placebo food supplement

Interventions

Saffr'Inside; 30mg DIETARY_SUPPLEMENT

Ingestion of one gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.

Group 1: Sleep intervention (ESE) & Saffron (food supplement); Group 3: No sleep intervention (Control ESE) & Saffron (food supplement)

Enhanced Sleep Education BEHAVIORAL

Psycho-education based multi-component sleep intervention

Group 1: Sleep intervention (ESE) & Saffron (food supplement); Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement)

Placebo food supplement DIETARY_SUPPLEMENT

Placebo food supplement identical to the active gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.

Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement); Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alpar S Lazar, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alpar S Lazar, PhD

CONTACT

01603 592605; a.lazar@uea.ac.uk

David Vauzour, PhD

CONTACT

01603 591732; d.vauzour@uea.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant's and Investigators will be blinded to which participants are receiving the dietary saffron supplement and placebo. Random allocation will be conducted by an independent researcher. Participants and investigators will not be blinded to which participants have been allocated ot the ESE intervention.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Forty-eight (i.e. n=12 per group; 4 groups) healthy older adults aged 55 and over with subjective sleep complaints will be recruited for this 4-week double blinded placebo controlled feasibility study. This project will adopt a 2 x 2 Factorial design.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: April 7, 2022
• Study Start: April 29, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 15, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available following completion of the study for a minimum of 10 years.
• Access Criteria: Data will only be shared with researchers at the UEA.