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Non-REm Sleep inTervention to improvE Diabetes RESTED (RESTED)

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ClinicalTrials.gov Identifier: NCT04120571
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
University of Leeds
Information provided by (Responsible Party):
University of Lincoln

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Sleep Audiological Intervention Device (SleepAID) Other: sham control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single centre - Crossover randomised controlled trial' design
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental
Sleep Audiological Intervention Device (SleepAID)
Other: Sleep Audiological Intervention Device (SleepAID)
subtle sound stimulation in phase with the slow oscillations

Sham Comparator: control
no sound
Other: sham control
no noise




Primary Outcome Measures :
  1. Blood glucose (CGM) [ Time Frame: Over 24 hours ]
    Continuous glucose monitoring (mmol/l)


Secondary Outcome Measures :
  1. Blood glucose (OGTT) [ Time Frame: 2 hours post bolus ingestion of glucose ]
    Oral glucose tolerance test (mmol/l)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Ffion Curtis 01522835732 fcurtis@lincoln.ac.uk
Contact: Graham Law 01522835762 glaw@lincoln.ac.uk

Locations
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United Kingdom
University of Lincoln Recruiting
Lincoln, Lincolnshire, United Kingdom, LN6 7TS
Contact: Ffion Curtis    7855802005    fcurtis@lincoln.ac.uk   
Contact: Graham Law    01522835762    glaw@lincoln.ac.uk   
Sponsors and Collaborators
University of Lincoln
University of Leeds

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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT04120571     History of Changes
Other Study ID Numbers: 18092
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases