Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05686655
• Other study ID #: soh-Med-22-12-05
• Status: Not yet recruiting
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: Sohag University
• Contact: Aml M Abdel wahab, resident
• Phone: 01148212777
• Email: aml011055[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sleep is an important health behavior for children and adolescents due to the impact it has on both mental and physical development. Although sleep is considered a resting period, it is also a period when the brain work to encode and consolidate memories into more stable representations for long term recall . Unfortunately, pediatric sleep disorders affect 25 - 40% of youth and several studies showed that children with chronic illness experience more problems with initiating and maintaining sleep than their non- chronically ill children .

Type 1 diabetes mellitus (T1DM) affects the quality of sleep in children and adolescents as well as their caregivers. Sleep disturbances in patients with T1DM may negatively impact their ability to manage their diabetes .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children and adolescents aged 6 to 15 years .

• diagnosed with T1DM for at least 6 months

• attending the pediatric diabetes outpatient clinic at Sohag University Hospital.

• Age and sex matched control group for acute non-serious illnesses

Exclusion Criteria:

• Children and adolescents with associated neurological or psychiatric disorders .

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• questionnaire about sleep quality in diabetic children
Pittsburgh sleep quality index

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Monzon A, McDonough R, Meltzer LJ, Patton SR. Sleep and type 1 diabetes in children and adolescents: Proposed theoretical model and clinical implications. Pediatr Diabetes. 2019 Feb;20(1):78-85. doi: 10.1111/pedi.12797. Epub 2018 Dec 4. — View Citation

Reutrakul S, Thakkinstian A, Anothaisintawee T, Chontong S, Borel AL, Perfect MM, Janovsky CC, Kessler R, Schultes B, Harsch IA, van Dijk M, Bouhassira D, Matejko B, Lipton RB, Suwannalai P, Chirakalwasan N, Schober AK, Knutson KL. Sleep characteristics in type 1 diabetes and associations with glycemic control: systematic review and meta-analysis. Sleep Med. 2016 Jul;23:26-45. doi: 10.1016/j.sleep.2016.03.019. Epub 2016 Jun 8. — View Citation

Suleiman KH, Yates BC, Berger AM, Pozehl B, Meza J. Translating the Pittsburgh Sleep Quality Index into Arabic. West J Nurs Res. 2010 Mar;32(2):250-68. doi: 10.1177/0193945909348230. Epub 2009 Nov 14. — View Citation

Turner SL, Queen TL, Butner J, Wiebe D, Berg CA. Variations in Daily Sleep Quality and Type 1 Diabetes Management in Late Adolescents. J Pediatr Psychol. 2016 Jul;41(6):661-9. doi: 10.1093/jpepsy/jsw010. Epub 2016 Mar 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of nighttime sleep in hours in night times and weekends	duration of nighttime sleep in hours in night times and weekends	in the past month
Primary	sleep problems as frequent awakening during the night	sleep problems as frequent awakening during the night	in the past month