InsomniaNCT05315986
Exploration of Relationships Between Sleep, Gut Health and Cognition
A study testing Saffr'Inside; 30mg and Enhanced Sleep Education in people with Insomnia and Sleep Disturbance, run by University of East Anglia.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Sleep Disturbance
- What is being tested?
- Saffr'Inside; 30mg and Enhanced Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Gut-sleep-brain Axis: Targeting the Gut Microbiota and Sleep Quality by Individualized Non-pharmaceutical Approaches to Promote Healthy Ageing.
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.
Read the 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 alarming given that cases of dementia are predicted to triple across the world by 2050.
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. The study aims to test the feasibility of using wearable sleep tracking EEG technology (DREEM3 device) to measure sleep quality in the home environment, which could contribute to a reliable but naturalistic and accessible future sleep research.
The study is split into 4 phases:
Screening phase: Participants will be asked to complete an online screening assessment to check for eligibility.
Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their cognitive functions, psychological well-being, and postural control. They will be asked to provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a baseline measure for testing supplement adherence and wear the DREEM3 headband device and complete a sleep diary to track their sleep quality with a high accuracy in their habitual home environment.
Intervention phase (4 weeks): Participants will be randomly assigned to 1 of 4 groups following a factorial design: Group 1: Food supplement \& ESE; Group 2: Food supplement \& No ESE (control); Group 3: Placebo (control) \& ESE, and Group 4: Placebo (control) \& No ESE (control). These groups will allow us to test the effectiveness of each non-pharmacological intervention for feasibility.
Follow-up assessment (1 week - overlap with the last week of intervention): Participants will be asked to measure their sleep at home using the DREEM3 EEG device and complete a sleep diary, and finally will be re-tested for cognitive performance, psychological wellbeing, and postural control. A follow-up faecal sample and urine sample will be collected as well.
This research predicts that it is feasible for sleep difficulties in older adults to be objectively assessed in the home environment and non-pharmacologically treated using food supplements and behavioural techniques. It endeavours to provide pilot evidence for the effectiveness of future individualized non-pharmaceutical sleep treatments in older people at risk of dementia.
- Conditions
- Insomnia, Sleep Disturbance
- Being tested
- Saffr'Inside; 30mg, Enhanced Sleep Education, Placebo food supplement
- Keywords
- sleep, polysomonography, food supplement, gut health, microbiome, cognition, EEG, Dreem3
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saffr'Inside; 30mgDietary supplement
Ingestion of one gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.
Enhanced Sleep EducationBehavioural
Psycho-education based multi-component sleep intervention
Placebo food supplementDietary supplement
Placebo food supplement identical to the active gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo.
Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo will be used to measure the feasibility of proposed treatment conditions to improve Psychological wellbeing. A decrease in scores indicates a decrease in experiences of low mood and improved psychological wellbeing. (highest score = 27, lowest score = 0)
Measured: 4 weeks
Changes in the time to complete (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo.
Changes in completion time (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo will be used measure changes in participants cognitive functioning. Decreases in completion time would suggest improve cognitive functioning.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start29 Apr 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alpar S Lazar, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315986
- Sponsor's protocol ID
- R210281
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may include: Participant contact details, Participant demographic information, Participant scores on screening questionnaires and DNA extracted from urine/fecal samples. Data will be shared with other researchers within the University of East Anglia (UEA) if Participants consent to this, so that individuals can be contacted of similar research studies going on at the UEA that they may be eligible to be enrolled in.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut-sleep-brain Axis: Targeting the Gut Microbiota and Sleep Quality by Individualized Non-pharmaceutical Approaches to Promote Healthy Ageing.
- ClinicalTrials.gov ID
- NCT05315986
- Acronym / sponsor ID
- R210281
- Conditions
- Insomnia, Sleep Disturbance
- Keywords
- sleep, polysomonography, food supplement, gut health, microbiome, cognition, EEG, Dreem3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 29 Apr 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 alarming given that cases of dementia are predicted to triple across the world by 2050.
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. The study aims to test the feasibility of using wearable sleep tracking EEG technology (DREEM3 device) to measure sleep quality in the home environment, which could contribute to a reliable but naturalistic and accessible future sleep research.
The study is split into 4 phases:
Screening phase: Participants will be asked to complete an online screening assessment to check for eligibility.
Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their cognitive functions, psychological well-being, and postural control. They will be asked to provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a baseline measure for testing supplement adherence and wear the DREEM3 headband device and complete a sleep diary to track their sleep quality with a high accuracy in their habitual home environment.
Intervention phase (4 weeks): Participants will be randomly assigned to 1 of 4 groups following a factorial design: Group 1: Food supplement \& ESE; Group 2: Food supplement \& No ESE (control); Group 3: Placebo (control) \& ESE, and Group 4: Placebo (control) \& No ESE (control). These groups will allow us to test the effectiveness of each non-pharmacological intervention for feasibility.
Follow-up assessment (1 week - overlap with the last week of intervention): Participants will be asked to measure their sleep at home using the DREEM3 EEG device and complete a sleep diary, and finally will be re-tested for cognitive performance, psychological wellbeing, and postural control. A follow-up faecal sample and urine sample will be collected as well.
This research predicts that it is feasible for sleep difficulties in older adults to be objectively assessed in the home environment and non-pharmacologically treated using food supplements and behavioural techniques. It endeavours to provide pilot evidence for the effectiveness of future individualized non-pharmaceutical sleep treatments in older people at risk of dementia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sleep intervention (ESE) & Saffron (food supplement) | Experimental | Dietary Supplement: Saffr'Inside; 30mg, Behavioral: Enhanced Sleep EducationSaffron: 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. |
| Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement) | Experimental | Behavioral: Enhanced Sleep Education, Dietary Supplement: Placebo food supplementPlacebo (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. |
| Group 3: No sleep intervention (Control ESE) & Saffron (food supplement) | Experimental | Dietary Supplement: Saffr'Inside; 30mgSaffron: 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. |
| Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement) | Placebo comparator | Dietary Supplement: Placebo food supplementPlacebo (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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saffr'Inside; 30mgIngestion of one gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks. | Dietary supplement | Group 1: Sleep intervention (ESE) & Saffron (food supplement), Group 3: No sleep intervention (Control ESE) & Saffron (food supplement) |
| Enhanced Sleep EducationPsycho-education based multi-component sleep intervention | Behavioural | Group 1: Sleep intervention (ESE) & Saffron (food supplement), Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement) |
| Placebo food supplementPlacebo food supplement identical to the active gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks. | Dietary supplement | Group 2: Sleep intervention (ESE) & No Saffron (placebo food supplement), Group 4: No sleep intervention (Control ESE) & No Saffron (placebo food supplement) |
Primary outcome
Number of nights on which participants used the Dreem headband over a 14 day period
Time frame: 2 weeks
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
Mean percentage of Dreem device signal quality over a 14 day period
Time frame: 2 weeks
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.
Number of Participants who report that they made changes to their sleeping habits following engagement in Enhanced Sleep Education (ESE).
Time frame: 4 weeks
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.
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.
Time frame: 4 weeks
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)
Changes in scores on the Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo.
Time frame: 4 weeks
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)
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.
Time frame: 4 weeks
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.
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.
Time frame: 4 weeks
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.
Mean number of days on which participants ingested the dietary supplements (Saffr'Inside) per subject over a 4 week period
Time frame: 4 weeks
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.
2 secondary outcomes
Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo.
Time frame: 4 weeks
Changes in the time to complete (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Yes. IPD may include: Participant contact details, Participant demographic information, Participant scores on screening questionnaires and DNA extracted from urine/fecal samples. Data will be shared with other researchers within the University of East Anglia (UEA) if Participants consent to this, so that individuals can be contacted of similar research studies going on at the UEA that they may be eligible to be enrolled in.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpar S Lazar, PhD principal investigator
University of East Anglia
Questions about this trial
What is this clinical trial studying?
A study testing Saffr'Inside; 30mg and Enhanced Sleep Education in people with Insomnia and Sleep Disturbance, run by University of East Anglia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alpar S Lazar, PhD (01603 592605, a.lazar@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of nights on which participants used the Dreem headband over a 14 day period (time frame: 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.