Clinical trial NCT05686655: Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus
Official title: Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents aged 6 to 15 years diagnosed with T1DM for at least 6 months and attending the pediatric diabetes outpatient clinic at Sohag University Hospital will be included in the study.

Age and sex matched control group will be included from children and adolescents attending the general pediatric outpatient clinic at Sohag University hospital for acute non-serious illnesses.

Brief 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 .


Eligibility criteria: 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 .

Primary outcomes:
measure: duration of nighttime sleep in hours in night times and weekends
timeFrame: in the past month
measure: sleep problems as frequent awakening during the night
timeFrame: in the past month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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.
citation: 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.
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.
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.