Non-REm Sleep inTervention to improvE Diabetes RESTED (RESTED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04120571|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: Sleep Audiological Intervention Device (SleepAID) Other: sham control||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Single centre - Crossover randomised controlled trial' design|
|Official Title:||Non-REm Sleep inTervention to improvE Diabetes RESTED|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||August 1, 2021|
Sleep Audiological Intervention Device (SleepAID)
Other: Sleep Audiological Intervention Device (SleepAID)
subtle sound stimulation in phase with the slow oscillations
Sham Comparator: control
Other: sham control
- Blood glucose (CGM) [ Time Frame: Over 24 hours ]Continuous glucose monitoring (mmol/l)
- Blood glucose (OGTT) [ Time Frame: 2 hours post bolus ingestion of glucose ]Oral glucose tolerance test (mmol/l)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120571
|Contact: Ffion Curtisemail@example.com|
|Contact: Graham Lawfirstname.lastname@example.org|
|University of Lincoln||Recruiting|
|Lincoln, Lincolnshire, United Kingdom, LN6 7TS|
|Contact: Ffion Curtis 7855802005 email@example.com|
|Contact: Graham Law 01522835762 firstname.lastname@example.org|