Topics

Non-REm Sleep inTervention to improvE Diabetes RESTED

2019-10-15 11:11:10 | BioPortfolio

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. 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.

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

Conditions

Type 2 Diabetes

Intervention

Sleep Audiological Intervention Device (SleepAID), sham control

Location

University of Lincoln
Lincoln
Lincolnshire
United Kingdom
LN6 7TS

Status

Recruiting

Source

University of Lincoln

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:11:10-0400

Clinical Trials [5949 Associated Clinical Trials listed on BioPortfolio]

Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine...

A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young ad...

A Sleep Intervention in Type 1 Diabetes

Insufficient sleep and sleep irregularity (variability in sleep duration) are increasingly recognized as important contributors to glucose control and diabetes distress in type 1 diabetes ...

A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain...

Effect of VeSTAL Device in Type 2 Diabetes Mellitus

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing Hb...

PubMed Articles [21620 Associated PubMed Articles listed on BioPortfolio]

Inadequate description of placebo and sham controls in a review of recent trials.

Poorly described placebo/sham controls inhibit appraisal of active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed t...

Association between mandibular advancement device therapy and reduction of excessive daytime sleepiness due to obstructive sleep apnoea.

Excessive daytime sleepiness (EDS) is frequently reported as a symptom for obstructive sleep apnoea (OSA), leading to problems with concentration, mood and memory. Mandibular advance device (MAD) is c...

Validity, potential clinical utility and comparison of a consumer activity tracker and a research-grade activity tracker in insomnia disorder II: Outside the laboratory.

Accurate assessment of sleep can be fundamental for monitoring, managing and evaluating treatment outcomes within diseases. A proliferation of consumer activity trackers gives easy access to objective...

Sleep quality among college students: exploring the role of a divine locus of sleep control.

To explore (a) how perceptions of personal and divine control over one's sleep schedule combine in distinct ways to predict sleep quality among college students and (b) whether health behaviors and ps...

Systematic review and meta-analysis of placebo/sham controlled randomised trials of spinal cord stimulation for neuropathic pain.

The aims of this study review were to: systematically identify the current evidence base of randomised controlled trials (RCTs) of spinal cord stimulation (SCS) placebo (or 'sham') trials for neuropat...

Medical and Biotech [MESH] Definitions

Periods of sleep manifested by changes in EEG activity and certain behavioral correlates; includes Stage 1: sleep onset, drowsy sleep; Stage 2: light sleep; Stages 3 and 4: delta sleep, light sleep, deep sleep, telencephalic sleep.

A study in which observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.

Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)

Movements or behaviors associated with sleep, sleep stages, or partial arousals from sleep that may impair sleep maintenance. Parasomnias are generally divided into four groups: arousal disorders, sleep-wake transition disorders, parasomnias of REM sleep, and nonspecific parasomnias. (From Thorpy, Sleep Disorders Medicine, 1994, p191)

A sleep disorder of central nervous system origin characterized by prolonged nocturnal sleep and periods of daytime drowsiness. Affected individuals experience difficulty with awakening in the morning and may have associated sleep drunkenness, automatic behaviors, and memory disturbances. This condition differs from narcolepsy in that daytime sleep periods are longer, there is no association with CATAPLEXY, and the multiple sleep latency onset test does not record sleep-onset rapid eye movement sleep. (From Chokroverty, Sleep Disorders Medicine, 1994, pp319-20; Psychiatry Clin Neurosci 1998 Apr:52(2):125-129)

More From BioPortfolio on "Non-REm Sleep inTervention to improvE Diabetes RESTED"

Quick Search

Searches Linking to this Trial