Digital sleep treatment for metabolic health in people who are at high risk of type 2 diabetes and have insomnia

Not Applicable

Completed

• Conditions: People who are at high risk of type 2 diabetes and have insomnia; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN19682964
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Study Completion: 2024-03-08
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. HbA1c 6-6.4% within the past 12 months and/or a diagnosis of pre-diabetes
2. Insomnia disorder
3. Reliable access to the internet
4. Capable of attending visits at the OCDEM Clinical Research Unit (CRU) at Oxford
5. Capable of complying with the study procedures and intervention
6. Able to understand study instructions in English
7. Age =18 years

Exclusion Criteria

1. Diagnosis of diabetes/prescribed diabetes medication
2. Prescribed sleep medication
3. Diagnosed or probable obstructive sleep apnea (OSA), narcolepsy, restless legs syndrome/periodic limb movement disorder, circadian sleep-wake rhythm disorder, parasomnia;
4. Psychosis (schizophrenia or bipolar disorder)
5. Shift worker
6. Dementia or mild cognitive impairment
7. Suicidal ideation with intent
8. Epilepsy
9. Pregnant/planning pregnancy
10. Previously accessed or used the Sleepio® programme or is a current user
11. Currently receiving psychological therapy for insomnia or enrolled in another sleep intervention trial
12. Allergy to hypoallergenic adhesive plasters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to recruit participants from primary care measured by site activity reports and recruitment rate during the planned study period (12 months).