MedTrace Logo

Non-REm Sleep inTervention to improvE Diabetes RESTED

NCT04120571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-11

No results posted yet for this study

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

Interventions

OTHER

Sleep Audiological Intervention Device (SleepAID)

subtle sound stimulation in phase with the slow oscillations

OTHER

sham control

no noise

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • University of Lincoln

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-11-01
Completion
2021-08-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120571 on ClinicalTrials.gov