Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05686655
Collaborator
(none)
150
1
12
12.5

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire about sleep quality in diabetic children

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
diabetes children

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

Outcome Measures

Primary Outcome Measures

  1. duration of nighttime sleep in hours in night times and weekends [in the past month]

    duration of nighttime sleep in hours in night times and weekends

  2. sleep problems as frequent awakening during the night [in the past month]

    sleep problems as frequent awakening during the night

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 15 Years
Sexes Eligible for Study:
All
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amal Mohamed Abdelwahab, resident at pediatric departement at el helal hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05686655
Other Study ID Numbers:
  • soh-Med-22-12-05
First Posted:
Jan 17, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2023