Type 2 DiabetesRESTEDNCT04120571
Non-REm Sleep inTervention to improvE Diabetes RESTED
A study testing Sleep Audiological Intervention Device (SleepAID) in people with Type 2 Diabetes, run by University of Lincoln at 1 site in United Kingdom.
Trial summary
Diabetes is a known risk factor for cardiovascular disease. This research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of future cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sleep Audiological Intervention Device (SleepAID)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Over 18 years of age
- Diagnosed with T2DM, as defined by WHO
- Managed by diet and metformin, for at least 3 months
- Able to speak and understand English
- A regular single-phase of sleep (ie. single period of sleep per 24 hours)
- Normally wakes before 09:00 am and achieves at least 6 hours of sleep
Who cannot join
- T2DM treated with any medication other than diet and metformin
- Change in regular medication during the study period
- Any other physical or psychological disease likely to interfere with the normal conduct of the study such as coeliac disease or untreated hypothyroidism
- Clinically-diagnosed Obstructive Sleep Apnoea
- Epworth Sleepiness Score above 10
- Prior history of drug, alcohol or solvent abuse
- Self-reported hearing loss or impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Lincoln
Lincoln, Lincolnshire, LN6 7TS
About this study
Diabetes is a known risk factor for cardiovascular disease. This research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of future cardiovascular events. The investigators propose that improved sleep health will result in improved glucose levels in participants with T2DM.
The investigators plan to use short bursts of sound (pink noise) during sleep to improve the deep-sleep phase. The study will be a 'crossover randomised controlled trial' in which two different treatments (intervention and control) are compared in all participants.
Read more
The study will be based at the University of Lincoln Sleep Laboratory. Participants will be recruited via local GP practices. Twenty five adults with T2DM who have normal sleeping patterns will be invited to attend the sleep laboratory on 3 nights, each visit separated by one week.
The primary outcome measure for this study will be the difference in mean glucose between the intervention and control periods over the first 24 hours after waking.
Participants will be fitted with sensors on their faces to measure muscle tone and eye-movements and scalps to measure brain activity (EEG) and earphones that will deliver the 'pink noise'. The first night will be a 'sham' visit with no intervention, and nights 2 and 3 will be randomised to either intervention or control. An oral glucose tolerance test will be performed on the mornings of visits 2 and 3. During visits 2 and 3 participants will be fitted with a continuous glucose monitor which will be worn for 7 days.
This is a feasibility study and the findings will be used to design a large randomised controlled trial. With the increasing prevalence of diabetes it is important to develop new approaches without the frequently observed side effects associated with pharmacological treatments to improve glucose control in patients with T2DM.
Read the detailed description
The proposed project uses a 'crossover randomised controlled trial' design, where two different treatments are compared in all participants. Each participant will therefore receive both treatments (sound intervention, and no intervention) and the project will compare the impact of the two treatments on the same participant. This means each person acts as their own control.
The research will be conducted in the newly built Sleep Laboratory at the University of Lincoln, which is composed of two participant bedrooms and an observation room. Participants will have access to a toilet and shower.
Potential participants will be identified by their General Practitioner (GP) by searching the practice database and screening records for eligibility. All eligible potential participants will receive a study information pack sent from the GP practice. There will be contact details to allow anyone wishing to take part to make contact with the study team having read the study information pack.
The investigators will also recruit via university email and staff web page. Potential participants may then contact the research team to request a study information pack which will be emailed or posted as above.
Screening Potential participants will express an interest in the study by contacting one of the research team. They will be screened over the phone by checking inclusion and exclusion criteria. If eligible to take part they will be invited to a recruitment visit with at least 24 hours to read the participant information sheet and ask any questions.
Recruitment visit - Day 1/2 Participants will attend the sleep laboratory at 9pm on day 1 of the study. They will have the opportunity to ask any questions and then if still happy to take part will give signed informed consent. Basic information on age, sex, height and weight will be collected. Their medical history will be checked and they will then be asked to complete 5 sleep related questionnaires to confirm that they meet eligibility criteria.
1.Pittsburgh Sleep Quality Index to measure sleep quantity and quality. 3.Epworth Sleepiness Scale to assess for Obstructive Sleep Apnoea Syndrome. 4.Horne-Östberg Morningness-Eveningness Questionnaire to measure chronotype. 5.Insomnia Severity Index to measure current levels of insomnia.
At subsequent visits participants will complete only the Pittsburgh Sleep Quality Index and Stanford Sleepiness Scale.
The participant will have EEG sensors attached to their scalp and given comfortable earphones (sleep phones) fitted.
At about 10 pm they will be left alone in the sleep laboratory to fall asleep. When they wake naturally the following morning (Day 2) the EEG sensors and sleep phones will be removed and they are free to leave.
Randomisation Each participant will be randomised to either receive the sound intervention on the 1st experimental night (visit 1) and no sound on the 2nd experimental night (visit 2) or vice versa. The patient will not know which order these are going to occur in.
The intervention The intervention is an auditory signal (50 millisecond burst of pink noise). The participants will be fitted with sensors on their face to examine eye-movements and muscle tone and sensors on the their scalp to detect the electrical activity of the brain using an EEG, whilst 50 millisecond bursts of 'pink noise' are delivered via sleep-comfortable earphones (sleep phones). The EEG is recorded via electrodes. After the scalp has been cleaned with NuPrep exfoliating gel (Weave and Company), active electrodes will be attached using appropriate conducting gel. A ground electrode is attached to the forehead.
Visit 1 - Day 8/9 The participant will attend the sleep laboratory again on day 8 at 9pm. They will be asked to complete the Pittsburgh Sleep Quality Index again. They will have the EEG sensors and sleep phones fitted. In addition they will have a CGMS fitted.
They will be left to sleep in the sleep laboratory overnight whilst the experimenter is next door, at no point during the study will the participant be left completely alone in the lab.Within 30 minutes of waking the following morning (day 9) they will be asked to fill in the Stanford Sleepiness Scale and drink 330ml of Rapilose glucose drink in under 5 minutes to provide a 75g bolus of glucose. Blood glucose measurements will be recorded using the CGM. Participants will need to sit quietly for 2 hours after drinking the Rapilose whilst the glucose levels are recorded and then are free to leave the laboratory. The CGMS will be worn until the next visit.
Visit 2 - Day 15/16 The participant will attend the sleep laboratory again on day 15 at 9pm. The CGMS will be removed and a new one fitted. They will be asked to complete the Pittsburgh Sleep Quality Index again. They will have the EEG sensors and sleep phones fitted.
They will be left to sleep in the sleep laboratory overnight whilst the experimenter is next door, at no point during the study will the participant be left completely alone in the lab. Within 30 minutes of waking the following morning (day 16) they will be asked to complete a 10-minute psychomotor vigilance task and to drink 330ml of Rapilose in under 5 minutes to provide a 75g bolus of glucose. Blood glucose measurements will be recorded using the CGMS. Participants will need to sit quietly for 2 hours after drinking the Rapilose whilst the glucose levels are recorded and then are free to leave the laboratory. The CGM will be worn until the next visit.
Visit 3 - Day 23 The participant will return to the sleep laboratory at a mutually convenient time and have the CGMS removed.
- Conditions
- Type 2 Diabetes
- Being tested
- Sleep Audiological Intervention Device (SleepAID), sham control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Audiological Intervention Device (SleepAID)Other
subtle sound stimulation in phase with the slow oscillations
sham controlOther
no noise
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Sleep Audiological Intervention Device (SleepAID) Receives: Other: Sleep Audiological Intervention Device (SleepAID) |
| control | Sham comparator | no sound Receives: Other: sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose (CGM)
Continuous glucose monitoring (mmol/l)
Measured: Over 24 hours
Secondary outcomes (1)
Blood glucose (OGTT)
Oral glucose tolerance test (mmol/l)
Measured: 2 hours post bolus ingestion of glucose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Apr 2019
- Primary completion1 Nov 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single centre - Crossover randomised controlled trial' design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120571
- Sponsor's protocol ID
- 18092
- Acronym
- RESTED
- Status last verified
- Oct 2019
- First submitted
- 7 Nov 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-REm Sleep inTervention to improvE Diabetes RESTED
- ClinicalTrials.gov ID
- NCT04120571
- Acronym / sponsor ID
- RESTED / 18092
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Oct 2019 (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.
Diabetes is a known risk factor for cardiovascular disease. This research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of future cardiovascular events. The investigators propose that improved sleep health will result in improved glucose levels in participants with T2DM.
The investigators plan to use short bursts of sound (pink noise) during sleep to improve the deep-sleep phase. The study will be a 'crossover randomised controlled trial' in which two different treatments (intervention and control) are compared in all participants.
The study will be based at the University of Lincoln Sleep Laboratory. Participants will be recruited via local GP practices. Twenty five adults with T2DM who have normal sleeping patterns will be invited to attend the sleep laboratory on 3 nights, each visit separated by one week.
The primary outcome measure for this study will be the difference in mean glucose between the intervention and control periods over the first 24 hours after waking.
Participants will be fitted with sensors on their faces to measure muscle tone and eye-movements and scalps to measure brain activity (EEG) and earphones that will deliver the 'pink noise'. The first night will be a 'sham' visit with no intervention, and nights 2 and 3 will be randomised to either intervention or control. An oral glucose tolerance test will be performed on the mornings of visits 2 and 3. During visits 2 and 3 participants will be fitted with a continuous glucose monitor which will be worn for 7 days.
This is a feasibility study and the findings will be used to design a large randomised controlled trial. With the increasing prevalence of diabetes it is important to develop new approaches without the frequently observed side effects associated with pharmacological treatments to improve glucose control in patients with T2DM.
Detailed description
The proposed project uses a 'crossover randomised controlled trial' design, where two different treatments are compared in all participants. Each participant will therefore receive both treatments (sound intervention, and no intervention) and the project will compare the impact of the two treatments on the same participant. This means each person acts as their own control.
The research will be conducted in the newly built Sleep Laboratory at the University of Lincoln, which is composed of two participant bedrooms and an observation room. Participants will have access to a toilet and shower.
Potential participants will be identified by their General Practitioner (GP) by searching the practice database and screening records for eligibility. All eligible potential participants will receive a study information pack sent from the GP practice. There will be contact details to allow anyone wishing to take part to make contact with the study team having read the study information pack.
The investigators will also recruit via university email and staff web page. Potential participants may then contact the research team to request a study information pack which will be emailed or posted as above.
Screening Potential participants will express an interest in the study by contacting one of the research team. They will be screened over the phone by checking inclusion and exclusion criteria. If eligible to take part they will be invited to a recruitment visit with at least 24 hours to read the participant information sheet and ask any questions.
Recruitment visit - Day 1/2 Participants will attend the sleep laboratory at 9pm on day 1 of the study. They will have the opportunity to ask any questions and then if still happy to take part will give signed informed consent. Basic information on age, sex, height and weight will be collected. Their medical history will be checked and they will then be asked to complete 5 sleep related questionnaires to confirm that they meet eligibility criteria.
1.Pittsburgh Sleep Quality Index to measure sleep quantity and quality. 3.Epworth Sleepiness Scale to assess for Obstructive Sleep Apnoea Syndrome. 4.Horne-Östberg Morningness-Eveningness Questionnaire to measure chronotype. 5.Insomnia Severity Index to measure current levels of insomnia.
At subsequent visits participants will complete only the Pittsburgh Sleep Quality Index and Stanford Sleepiness Scale.
The participant will have EEG sensors attached to their scalp and given comfortable earphones (sleep phones) fitted.
At about 10 pm they will be left alone in the sleep laboratory to fall asleep. When they wake naturally the following morning (Day 2) the EEG sensors and sleep phones will be removed and they are free to leave.
Randomisation Each participant will be randomised to either receive the sound intervention on the 1st experimental night (visit 1) and no sound on the 2nd experimental night (visit 2) or vice versa. The patient will not know which order these are going to occur in.
The intervention The intervention is an auditory signal (50 millisecond burst of pink noise). The participants will be fitted with sensors on their face to examine eye-movements and muscle tone and sensors on the their scalp to detect the electrical activity of the brain using an EEG, whilst 50 millisecond bursts of 'pink noise' are delivered via sleep-comfortable earphones (sleep phones). The EEG is recorded via electrodes. After the scalp has been cleaned with NuPrep exfoliating gel (Weave and Company), active electrodes will be attached using appropriate conducting gel. A ground electrode is attached to the forehead.
Visit 1 - Day 8/9 The participant will attend the sleep laboratory again on day 8 at 9pm. They will be asked to complete the Pittsburgh Sleep Quality Index again. They will have the EEG sensors and sleep phones fitted. In addition they will have a CGMS fitted.
They will be left to sleep in the sleep laboratory overnight whilst the experimenter is next door, at no point during the study will the participant be left completely alone in the lab.Within 30 minutes of waking the following morning (day 9) they will be asked to fill in the Stanford Sleepiness Scale and drink 330ml of Rapilose glucose drink in under 5 minutes to provide a 75g bolus of glucose. Blood glucose measurements will be recorded using the CGM. Participants will need to sit quietly for 2 hours after drinking the Rapilose whilst the glucose levels are recorded and then are free to leave the laboratory. The CGMS will be worn until the next visit.
Visit 2 - Day 15/16 The participant will attend the sleep laboratory again on day 15 at 9pm. The CGMS will be removed and a new one fitted. They will be asked to complete the Pittsburgh Sleep Quality Index again. They will have the EEG sensors and sleep phones fitted.
They will be left to sleep in the sleep laboratory overnight whilst the experimenter is next door, at no point during the study will the participant be left completely alone in the lab. Within 30 minutes of waking the following morning (day 16) they will be asked to complete a 10-minute psychomotor vigilance task and to drink 330ml of Rapilose in under 5 minutes to provide a 75g bolus of glucose. Blood glucose measurements will be recorded using the CGMS. Participants will need to sit quietly for 2 hours after drinking the Rapilose whilst the glucose levels are recorded and then are free to leave the laboratory. The CGM will be worn until the next visit.
Visit 3 - Day 23 The participant will return to the sleep laboratory at a mutually convenient time and have the CGMS removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single centre - Crossover randomised controlled trial' design
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Sleep Audiological Intervention Device (SleepAID)Sleep Audiological Intervention Device (SleepAID) |
| control | Sham comparator | Other: sham controlno sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to give informed consent
- Over 18 years of age
- Diagnosed with T2DM, as defined by WHO
- Managed by diet and metformin, for at least 3 months
- Able to speak and understand English
Key exclusion criteria (7 listed)
- T2DM treated with any medication other than diet and metformin
- Change in regular medication during the study period
- Any other physical or psychological disease likely to interfere with the normal conduct of the study such as coeliac disease or untreated hypothyroidism
- Clinically-diagnosed Obstructive Sleep Apnoea
- Epworth Sleepiness Score above 10
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 |
|---|---|---|
| Sleep Audiological Intervention Device (SleepAID)subtle sound stimulation in phase with the slow oscillations | Other | experimental |
| sham controlno noise | Other | control |
Primary outcome
Blood glucose (CGM)
Time frame: Over 24 hours
Continuous glucose monitoring (mmol/l)
1 secondary outcome
Blood glucose (OGTT)
Time frame: 2 hours post bolus ingestion of glucose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Audiological Intervention Device (SleepAID) in people with Type 2 Diabetes, run by University of Lincoln at 1 site in United Kingdom.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (CGM) (time frame: Over 24 hours). 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 11 Dec 2024.