Last updated: March 13, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Insomnia
Treatment
cognitive behavioral therapy for insomnia
Health education
Clinical Study ID
NCT06202742
MURA2023/873
Ages 30-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Type 2 diabetes mellitus age 30 to 65 years old
- Hemoglobin A1C ≥ 6.5 but ≤ 10 %
- Have poor sleep quality as assessed by Insomnia Severity Index ≥ 15
- Receive the same hypoglycemic treatments 3 months before the intervention
- If using sleep aid, the dose needs to be stable for 3 months prior to the enrollment
- Ability to use the electronic devices (computer, tablet) and assess the internet
- Willing to attend all of the 8 sessions activities
Exclusion
Exclusion Criteria:
- Type 1 diabetes mellitus
- Night shift work
- Insulin therapy
- Severe hypoglycemia who required hospitalization or emergency department visit in thepast 6 months
- History of diabetic ketoacidosis in the past 6 months
- Medically unstable conditions eg. renal replacement therapy, liver failure, heartfailure, active cancer, epilepsy, unstable cerebrovascular disease
- Psychosis, uncontrolled depression
- Untreated obstructive sleep apnea or STOP-BANG ≥ 5
- Language/communication/hearing/sight disability
- Pregnancy or lactation
- Care giver of infant
- Harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: cognitive behavioral therapy for insomnia
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, 10400
ThailandActive - Recruiting

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