Non-REm Sleep inTervention to improvE Diabetes RESTED

NCT04120571 | Completed

• 1 other identifier: 18092
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Blood glucose (CGM)

  Continuous glucose monitoring (mmol/l)

  Over 24 hours

Secondary Outcomes (1)

• Blood glucose (OGTT)

  2 hours post bolus ingestion of glucose

Study Arms (2)

experimental

EXPERIMENTAL

Sleep Audiological Intervention Device (SleepAID)

Other: Sleep Audiological Intervention Device (SleepAID)

control

SHAM COMPARATOR

no sound

Other: sham control

Interventions

Sleep Audiological Intervention Device (SleepAID) OTHER

subtle sound stimulation in phase with the slow oscillations

experimental

sham control OTHER

no noise

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lincoln: lead
• University of Leeds: collaborator

Study Sites (1)

University of Lincoln

Lincoln, Lincolnshire, LN6 7TS, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre - Crossover randomised controlled trial' design

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: October 9, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: August 1, 2021
• Last Updated: December 11, 2024

Record last verified: 2019-10

Locations

GB (1)