NCT05686655

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 9, 2023

Last Update Submit

January 9, 2023

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • 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

  • sleep problems as frequent awakening during the night

    sleep problems as frequent awakening during the night

    in the past month

Study Arms (1)

diabetes children

Other: questionnaire about sleep quality in diabetic children

Interventions

questionnaire about sleep quality in diabetic childrenOTHER

Pittsburgh sleep quality index

diabetes children

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Children and adolescents with associated neurological or psychiatric disorders .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 27692274BACKGROUND

  • 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.

    PMID: 30447038BACKGROUND

  • 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.

    PMID: 26994852BACKGROUND

  • 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.

    PMID: 19915205BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Aml M Abdel wahab, resident

CONTACT

01148212777aml011055@med.sohag.edu.eg

safaa H Ali, associate professor

CONTACT

01064818849

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at pediatric departement at el helal hospital

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 17, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

EG(1)